RegulationOrphan Drug (United States), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Regenerative Medicine Advanced Therapy (United States)

Structure/Sequence

Sequence Code 1275971141

Source: *****

Clinical Trials associated with Satricabtagene autoleucel

NCT06857786

/ Not yet recruitingPhase 1IIT

Open Label, Multicenter, Phase Ib Trial of CT041, Claudin 18.2 Specific CAR T Cell Therapy As a Consolidation Therapy After Adjuvant Therapy for Resected Gastric or Gastroesophageal Junction Adenocarcinoma Patients

To evaluate the safety and tolerability of satri-cel as consolidation therapy after postoperative adjuvant therapy in patients with resected gastric or gastroesophageal junction (G/GEJ) adenocarcinoma

Start Date10 Mar 2025

Sponsor / Collaborator

Peking University

NCT05911217

/ RecruitingPhase 1

An Open-label, Single-arm, Multicenter, Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of CT041 Autologous CAR T Cell Injection After Adjuvant Chemotherapy in Subjects With Pancreatic Cancer

An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.

Start Date11 Jul 2023

Sponsor / Collaborator

CARsgen Therapeutics Co. Ltd.

[+1]

NCT04581473

/ RecruitingPhase 1/2

An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer

An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer

Start Date23 Oct 2020

Sponsor / Collaborator

CARsgen Therapeutics Co. Ltd.

[+1]

100 Clinical Results associated with Satricabtagene autoleucel

100 Translational Medicine associated with Satricabtagene autoleucel

100 Patents (Medical) associated with Satricabtagene autoleucel

Literatures (Medical) associated with Satricabtagene autoleucel

01 Jun 2025·LANCET

Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial

Article

Author: Wei, Jia ; Yuan, Xianglin ; Gai, Lun ; Zhang, Xizhi ; Liu, Anwen ; Lin, Xiaoyan ; Qi, Changsong ; Shen, Lin ; Liu, Chang ; Wang, Yumeng ; Lin, Tongyu ; Pan, Hongming ; Qiu, Wensheng ; Niu, Zuoxing ; Hu, Changlu ; Yuan, Daijing ; Peng, Zhi ; Ye, Feng ; Zhang, Jun ; Qiu, Meng ; Zhang, Yanqiao ; Zhang, Xiaotian ; Li, Ning ; Wang, Shubin ; Fang, Weijia ; Cui, Jiuwei ; Qin, Yanru ; Li, Jian ; Li, Zonghai ; Qu, Xiujuan ; Gong, Jifang ; Zhang, Jian ; Liu, Tianshu ; Gao, Wanwan

BACKGROUND:

Claudin-18 isoform 2 (CLDN18.2) has emerged as a promising therapeutic target in gastric or gastro-oesophageal junction cancer. Satricabtagene autoleucel (satri-cel; also known as CT041), an autologous CLDN18.2-specific chimeric antigen receptor (CAR) T-cell therapy, showed encouraging activity in previously treated patients with advanced gastric or gastro-oesophageal junction cancer in phase 1 clinical trials. In this Article, we report the primary results from the phase 2 pivotal trial (CT041-ST-01) investigating the efficacy and safety of satri-cel for gastric or gastro-oesophageal junction cancer.

METHODS:

In this open-label, multicentre, randomised controlled trial conducted in China, patients with CLDN18.2-positive (immunohistochemistry expression intensity ≥2+ and positive tumour cells ≥40%) advanced gastric or gastro-oesophageal junction cancer, who were refractory to at least two previous lines of treatment, were randomly allocated (2:1) to receive satri-cel or treatment of physician's choice (TPC). In the satri-cel group, satri-cel was infused up to three times at a dose of 250 × 10⁶ cells. For the TPC group, one of the standard-of-care drugs (nivolumab, paclitaxel, docetaxel, irinotecan, or rivoceranib [apatinib]) was given, per the physician's decision. Those who had disease progression or drug intolerance in the TPC group could receive subsequent satri-cel, if eligible. The primary endpoint was progression-free survival, assessed by an independent review committee, in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT04581473), and is closed to new patients.

FINDINGS:

Between March 22, 2022, and July 29, 2024, 266 patients were screened, of whom 156 were randomly allocated to the satri-cel group (n=104) or TPC group (n=52). 88 (85%) patients in the satri-cel group and 48 (92%) patients in the TPC group received study drug. In the satri-cel group, 28 (27%) patients had previously received three or more lines of treatment and 72 (69%) patients had peritoneal metastasis. In the TPC group, ten (19%) patients had previously received three or more lines of treatment and 31 (60%) patients had peritoneal metastasis. The median follow-up time for progression-free survival was 9·07 months (95% CI 6·21-13·01) in the satri-cel group and 3·45 months (2·89-not estimable) in the TPC group, based on the reverse Kaplan-Meier method. In the intention-to-treat population, median progression-free survival was 3·25 months (95% CI 2·86-4·53) in the satri-cel group and 1·77 months (1·61-2·04) in the TPC group (hazard ratio 0·37 [95% CI 0·24-0·56]; one-sided log-rank p<0·0001). In the safety analysis set (all patients who received at least one dose of study drug), grade 3 or higher treatment-emergent adverse events occurred in 87 (99%) of 88 patients in the satri-cel group and 30 (63%) of 48 patients in the TPC group. The most common grade 3 or worse treatment-emergent adverse events related to treatment were decreased lymphocyte count (86 [98%] of 88 patients), decreased white blood cell count (68 [77%] patients), and decreased neutrophil count (58 [66%] patients) in the satri-cel group. Cytokine release syndrome occurred in 84 (95%) of 88 patients in the satri-cel group.

INTERPRETATION:

This is the first randomised controlled trial of CAR T-cell therapy in solid tumours globally. Satri-cel treatment resulted in a significant improvement in progression-free survival, with a manageable safety profile. These results support satri-cel as a new third-line treatment for advanced gastric or gastro-oesophageal junction cancer patients.

FUNDING:

CARsgen Therapeutics.

01 Feb 2025·iScience

Exploring the therapeutic efficacy difference in claudin18.2-targeted cell therapy revealed by single-cell sequencing

Article

Author: Zhang, Miao ; Shen, Lin ; Li, Jian ; Liu, Chang ; Gong, Jifang ; Tao, Min ; Deng, Mi ; Zhang, Panpan ; Qi, Changsong ; Zheng, Chunhong ; Liu, Dan ; Peng, Zhi ; Jiang, Lei ; Ma, Mingyang ; Zhang, Xiaotian

Chimeric antigen receptor T cell (CAR T) therapy has been successfully used to treat hematological malignancies. Nonetheless, its application to solid tumors remains challenging. Our previous analysis of the ongoing clinical trial (NCT03874897) demonstrated promising results in patients with advanced CLDN18.2-positive gastric cancer who received CT041 CAR T treatment. Here, we collected peripheral blood and ascites from five patients from the clinical trial 3 and 7 days (d) after CT041 infusion. Patients with a high proportion of naïve-like T cells were more likely to benefit from CT041 treatment. We found that high expression of CLDN18 in ascites epithelial cells correlated with a favorable prognosis, whereas ascites epithelial cells with high MYC expression and strong interactions between tumor cells and T cells were adverse prognostic factors for CT041 treatment. These findings may provide theoretical evidence for the screening of populations that can benefit from CAR T therapy and improve the efficacy of CAR T therapy.

01 Sep 2024·JOURNAL OF CLINICAL ONCOLOGY

Erratum: Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A Pooled Analysis of Two Early-Phase Trials

News (Medical) associated with Satricabtagene autoleucel

15 Aug 2025

·www.prnewswire.com

CARsgen Therapeutics Announces 2025 Interim Results

SHANGHAI, Aug. 14, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, has announced its 2025 Interim Results. Business Highlights Continue Reading CARsgen Pipeline Cash and bank balances were around RMB1,261 million as of June 30, 2025. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,100 million. We expect to have adequate cash into the 2028 excluding subsequent cash inflows. During H1 2025, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities. CARsgen has received a total of 111 confirmed orders from its commercialization partner Huadong Medicine. The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satri-cel. The results of satri-cel confirmatory Phase II trial in China have been published in The Lancet and at the 2025 ASCO Annual Meeting. Multiple allogeneic CAR-T products are in development, covering treatment areas such as hematologic malignancies, solid tumors, and autoimmune diseases. CARsgen introduced Zhuhai SB Xinchuang to accelerate allogeneic CAR-T development in mainland China. Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "In the first half of 2025, we made significant strides across technology innovation, product development, and commercialization. Zevor-cel sales surged, while satri-cel became the world's first CAR-T targeting solid tumors to file an NDA. We are also advancing multiple allogeneic CAR-T therapies to enhance clinical outcomes and expand patient access." Financial Highlights CARsgen's revenue was around RMB51 million for the six months ended June 30, 2025, mainly from zevor-cel, which was calculated on the basis of ex-works price, rather than end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. CARsgen's gross profit was around RMB29 million for the six months ended June 30, 2025. In the commercialization stage, we are demonstrating a strong cost competitive advantage, which is mainly due to self-manufacture for plasmids and vectors with stable output and high yield per batch. Cash and bank balances were around RMB1,261 million as of June 30, 2025, representing a decrease of around RMB218 million from around RMB1,479 million as of December 31, 2024. The decrease was mainly due to the payment of research and development expenses, administrative expenses and investment of capital expenditure. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,100 million. We expect to have adequate cash into the 2028 excluding subsequent cash inflows. Zevor-cel Demonstrates Rapid Sales Growth Zevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA) approved by the NMPA of China for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent). CARsgen entered into a collaboration agreement with Huadong Medicine (000963.SZ) for the commercialization of zevor-cel in mainland China. In terms of commercialization, Huadong Medicine has established a dedicated, professional, and comprehensive commercial team to promote the use of zevor-cel and has been utilizing China's multi-layered insurance system to improve patient accessibility. During the first half of 2025, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities and we have received a total of 111 confirmed orders from Huadong Medicine. We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage. Satri-cel NDA Accepted for Review in China Satricabtagene autoleucel (satri-cel, R&D code: CT041) is an autologous humanized CAR T-cell product against Claudin18.2 (CLDN18.2). In June 2025, the CDE of NMPA of China has accepted the New Drug Application (NDA) for satri-cel for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Satri-cel is the first and only CAR T-cell product globally for which an NDA submitted for the treatment of solid tumors. Satri-cel was granted Priority Review in May 2025 and Breakthrough Therapy Designation (BTD) in March 2025 by the CDE. The results of satri-cel confirmatory Phase II trial (NCT04581473) in China have been published in The Lancet and were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Satri-cel demonstrated significant progression-free survival (PFS) improvement and a clinically meaningful overall survival (OS) benefit with a manageable safety profile, compared to standard therapy. Multiple Allogeneic CAR-T Product Candidates in Development CARsgen has been advancing differentiated allogeneic CAR T-cell products utilizing the proprietary THANK-uCAR® platform. CARsgen has recently developed the THANK-u PlusTM platform as an enhanced version of THANK-uCAR® to address the potential impact of NKG2A expression levels on therapeutic efficacy of the allogeneic CAR T-cells. CT0596 is an allogeneic BCMA-targeted CAR T-cell product utilizing THANK-u Plus™ platform for the treatment of R/R MM and R/R plasma cell leukemia (PCL). The investigator-initiated trials (IITs) are ongoing in China. Preliminary clinical data for CT0596 were released in May 2025 on CARsgen's official website. Based on the preliminary safety and efficacy data, CT0596 demonstrated favorable tolerability and encouraging efficacy signals in R/R MM patients across all predefined dose levels, with CAR-T expansion observed. In addition, there are several allogeneic CAR T-cell products under development: KJ-C2219: Targeting CD19/CD20, for the treatment of hematologic malignancies and autoimmune diseases. An IIT for relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) has been initiated at the end of 2024. A separate IIT for systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) has been initiated in the first half of 2025. KJ-C2320: Targeting CD38, for the treatment of acute myeloid leukemia (AML). An IIT has been initiated at the end of 2024. KJ-C2114: For the treatment of solid tumors. KJ-C2526: Targeting NKG2DL, for the treatment of AML, other malignancies, and senescence. On February 25, 2025, CARsgen has entered into the agreements (the "Agreements") with an investment fund (the "Investor") managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership), pursuant to which, among others, the Investor has agreed to subscribe to additional registered capital of UCARsgen Biotech Limited ("UCARsgen") at a cash consideration of RMB80,000,000, representing 8% stake of the enlarged registered capital of UCARsgen. Upon the completion of the capital increase, CARsgen's share in UCARsgen will be diluted from 100% to 92%. UCARsgen is a China-based new drug discovery biotechnology company focused on allogeneic CAR T-cell therapies for the treatment of hematologic malignancies. Under the Agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR T-cell products from CARsgen: the BCMA-targeted allogeneic CAR T-cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR T-cell therapy for the treatment of B-cell malignancies (excluding indications for the treatment of autoimmune diseases). About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. For more information, please visit SOURCE CARsgen Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultCell TherapyDrug ApprovalBreakthrough Therapy

26 Jun 2025

·www.prnewswire.com

CARsgen Therapeutics Announces NDA Acceptance of Satri-cel by China's NMPA

SHANGHAI, June 25, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. The NDA submission is mainly based on the results of an open-label, multicenter, randomized controlled confirmatory Phase II clinical trial (CT041-ST-01, NCT04581473) conducted in China. The data have been presented in The Lancet and at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. In addition, the company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer, including an ongoing Phase Ib registrational trial for pancreatic cancer adjuvant treatment and an ongoing investigator-initiated trial for consolidation treatment following adjuvant therapy in patients with resected G/GEJA. Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of the CT041-ST-01 clinical trial, said, "Gastric cancer is a malignancy with a substantial global disease burden and significant treatment challenges. For patients with advanced gastric cancer, in particular, existing therapeutic options and their efficacy remain severely limited, resulting in extremely poor survival outcomes. Within the current treatment landscape for gastric cancer, a growing number of patients have experienced failure with immunotherapy and anti-angiogenic therapies. Treatment choices and potential benefits become even more constrained in the third-line setting and beyond. Consequently, there exists a significant unmet clinical need for advanced gastric cancer patients after second-line treatment failure. The confirmatory randomized controlled clinical trial of satri-cel has clearly demonstrated that, compared with existing standard therapies, satri-cel offers significant advantages and clinical value in extending both progression-free survival (PFS) and overall survival (OS). The trial results have garnered widespread international attention and recognition, providing a solid evidentiary foundation for satri-cel's New Drug Application (NDA) submission. We look forward to the approval and market launch of satri-cel, which will offer a new treatment option for the broader population of gastric cancer patients." Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are delighted to announce that the NDA for our self-developed Claudin18.2-targeted CAR T-cell product satri-cel has been accepted for review by China's NMPA. This marks the world's first CAR T-cell therapy product for solid tumors to reach the NDA stage—a major milestone for the CAR-T field. I extend my sincere gratitude to all clinical investigators, trial coordinators, and patients involved in this program. We are hopeful for its timely approval to provide gastric cancer patients with a new treatment option." About Satri-cel Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib registrational trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China's NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA for the treatment of G/GEJA in September 2020. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit SOURCE CARsgen Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Orphan DrugImmunotherapyCell TherapyBreakthrough Therapy

02 Jun 2025

·www.prnewswire.com

CARsgen Presents Research Results on Satri-cel in The Lancet and at the 2025 ASCO Annual Meeting

SHANGHAI, June 1, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the results of the pivotal Phase II clinical trial in China (CT041-ST-01, NCT04581473) investigating satricabtagene autoleucel ("satri-cel", CT041) (a Claudin18.2-specific autologous CAR T-cell product candidate) in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment, have been published in The Lancet and were orally presented at the 2025 ASCO Annual Meeting. Further details have been posted on the corporate website . The article in The Lancet was titled "Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial". Full article available at: (25)00860-8. The oral presentation at the 2025 ASCO Annual Meeting (Abstract 4003) was titled "Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01)". Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of this study, said, "The CT041-ST-01 trial represents the world's first randomized controlled clinical study of CAR-T cell therapy for solid tumors. In patients with heavily pretreated, advanced gastric/gastroesophageal junction cancer who have extremely limited treatment options and poor prognosis, satri-cel has demonstrated breakthrough efficacy with significant clinical benefits, including much improved progression-free survival (PFS), overall survival (OS), and tumor response rates. This brings new hope to patients with otherwise medically untreatable conditions. We are further exploring satri-cel's potential in adjuvant settings and as first-line sequential therapies, aiming to intervene earlier in the disease course, extend patients' survival, and ultimately pursue potential cures." Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are honored that the CT041-ST-01 study results were published in The Lancet—a premier, global medical journal—and presented at the 2025 ASCO Annual Meeting. The positive result of this randomized controlled trial marks a major milestone in solid tumor CAR-T therapy. These achievements are a testament to the whole research team's years of dedication, and we extend our deepest gratitude to patients and their families for their trust and participation. This year, satri-cel has been granted Breakthrough Therapy Designation and Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. We plan to submit a New Drug Application (NDA) for satri-cel to the NMPA this month and anticipate its approval as the world's first commercially available CAR-T product for solid tumors, bringing benefits to patients." About Satri-cel Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit SOURCE CARsgen Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Orphan DrugBreakthrough TherapyCell TherapyImmunotherapy

100 Deals associated with Satricabtagene autoleucel

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	NDA/BLA	China	Shanghai Keji Pharmaceutical Co. Ltd.	26 Jun 2025
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	NDA/BLA	China	Kaixing Life Technology (Shanghai) Co., Ltd.	26 Jun 2025
CLDN18.2 positive Stomach Cancer	NDA/BLA	China	Kaixing Life Technology (Shanghai) Co., Ltd.	26 Jun 2025
CLDN18.2 positive Stomach Cancer	NDA/BLA	China	Shanghai Keji Pharmaceutical Co. Ltd.	26 Jun 2025
Gastroesophageal junction adenocarcinoma	Phase 2	China	CARsgen Therapeutics Co. Ltd.	04 Mar 2022
Advanced Gastric Adenocarcinoma	Phase 2	United States	CARsgen Therapeutics Co. Ltd.	23 Oct 2020
Advanced Gastric Adenocarcinoma	Phase 2	China	Shanghai Keji Pharmaceutical Co. Ltd.	23 Oct 2020
Advanced Gastric Adenocarcinoma	Phase 2	Canada	CARsgen Therapeutics Co. Ltd.	23 Oct 2020
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 2	China	CARsgen Therapeutics Co. Ltd.	23 Oct 2020
Pancreatic Cancer	Phase 2	United States	CARsgen Therapeutics Co. Ltd.	23 Oct 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03874897 (CT041-CG4006, ESMO_GI2025)	Phase 1	Stomach Cancer GZMK+CD8+ T-lymphocytes \| IL6+ fibroblasts	35	CT041 (Responders)	juaqohblni(ptqdvnwcmm) = muoerojqzc dxtanwnkoh (bmlcacssga ) View more	Positive	03 Jul 2025
				CT041 (Non-responders)	juaqohblni(ptqdvnwcmm) = zdkclouumt dxtanwnkoh (bmlcacssga ) View more
NCT04581473 (CT041-ST-01, ASCO2025) Manual	Phase 2	Advanced gastric carcinoma \| Gastrooesophageal junction cancer CLDN18.2 Positive	156	Satri-cel	dxztywnoms(pgwadvqsmm) = oeuqdoeiwx jfsnjvvhzn (ncjckrfish ) View more	Positive	30 May 2025
				Treatment of Physician's Choice (TPC)	dxztywnoms(pgwadvqsmm) = tjqtotpcsh jfsnjvvhzn (ncjckrfish ) View more
NCT04581473 (CT041-ST-01, Pubmed) Manual	Phase 2	Gastrooesophageal junction cancer \| Advanced gastric carcinoma CLDN18.2 Positive	156	Satricabtagene autoleucel	tizxvmcdrv(irdnmbodsa) = lcjuhafwge rvibgmsjej (cxeougzhiy, 2.86 - 4.53) View more	Positive	01 May 2025
				treatment of physician's choice (TPC)	tizxvmcdrv(irdnmbodsa) = sfduxslzny rvibgmsjej (cxeougzhiy, 1.61 - 2.04) View more
NEWS \| Haematologica Manual	Not Applicable	Follicular Lymphoma \| Diffuse Large B-Cell Lymphoma	41	tisa-cel CAR-T细胞治疗	cqoxbzfpsi(svopjmdeuw) = yrnjpqcnie ntooemfmba (qgzlyliqtg ) View more	Positive	23 Jan 2025
NCT04581473 (CT041-ST-01, NEWS) Manual	Phase 2	Stomach Cancer Last line \| Third line CLDN18.2 Positive	-	舒瑞基奥仑赛	rgopdqzjzu(edjtaintim) = 具有统计学意义上的显著改善。 kbugblgwaw (vzgjmkyanj ) Met View more	Positive	30 Dec 2024
				研究者选择治疗组（包括紫杉醇、多西他赛、伊立替康、阿帕替尼或纳武利尤单抗）
NCT03874897 (CT041-CG4006, Pubmed) Manual	Phase 1	Gastrointestinal Neoplasms CLDN18.2 Positive	98	Satricabtagene autoleucel (satri-cel)/CT041 (dose-escalation stage)	svddotowhm(qnvtdfrugq) = None fduyxlurkg (qnrwipytrb ) View more	Positive	03 Jun 2024
				Satri-cel monotherapy (dose-expansion stage)
NCT04581473 \| NCT03874897 (CT041-ST-01, Pubmed) Manual	Not Applicable	Metastatic Pancreatic Cancer	24	CT041	vrjupddzwa(inbgksgkyx) = The most common treatment-emergent adverse events of grade 3 or more were preconditioning-related hematologic toxicities. Cytokine release syndrome (CRS) and GI disorders were most reported grade 1 or 2 adverse events. hnvtssssky (vlsavetvie ) View more	Positive	24 May 2024
NCT03874897 (CT041-CG4006, ASCO2024) Manual	Phase 1	Gastrointestinal Neoplasms First line CLDN18.2 Positive	98	CT041 in pretreated pts with advanced GI cancersCT041 in pretreated pts with advanced GI cancers	nqdhbbklif(dhilmbbmvk) = grade 3 or higher were hematologic toxicity related to lymphodepletion wscojrearr (ihcgvqprls ) View more	Positive	24 May 2024
				CT041 sequential treatment following first-line therapy in gastric cancer (GC)CT041 sequential treatment following first-line therapy in gastric cancer (GC)
NCT04404595 (ELIMYN18.2, PRNewswire) Manual	Phase 1/2	Prostatic Cancer \| CLDN18.2 positive Gastrooesophageal junction cancer \| CLDN18.2 positive Stomach Cancer CLDN18.2 Positive	19	satri-cel (GC/GEJ)	zynxddpbmm(xnqtzguvcl) = rwvzrkveqz rddzsklzcj (fjpnjcnlyi ) View more	Positive	19 Jan 2024
				satri-cel (DL3：600×106)	qwxwrbpxoa(vympujnpxo) = wijvpeudqy lpzhfkylvd (kqotemllti ) View more
NCT04581473 (CT041-ST-01, ASCO2022) Manual	Phase 1/2	Advanced Gastric Adenocarcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma Claudin-18 isoform 2 Expression	14	CT041	wnlrcolygn(eqchsovhkg) = Most CRS were grade 1 or 2, and only one patient experienced grade 4 CRS and fully recovered knodraymmb (tzookcgxzb ) View more	Positive	02 Jun 2022

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