CT0596 CAR-T Cell

SHANGHAI, June 14, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces poster presentations for CT0596 (an allogeneic CAR T-cell product targeting BCMA), and CT1190B (an allogeneic CAR T-cell product targeting CD19/CD20) at the 2026 Annual Congress of the European Hematology Association ("EHA"). Data for CT0596 in Relapsed/Refractory Multiple Myeloma and Primary Plasma Cell Leukemia Eight patients, including 6 relapsed/refractory multiple myeloma (R/RMM) and 2 relapsed/refractory primary plasma cell leukemia (R/R pPCL), received CT0596 at the 4.5×10⁸ CAR⁺ T cell dose level. All patients were heavily pretreated, with a median of 3.5 prior lines of therapy (range 2, 6). Most patients had advanced disease (ISS Stage III: n=5), 1 had extramedullary disease, and 5 patients had high-risk cytogenetics. All 8 patients reported treatment-emergent adverse events (TEAEs), primarily hematologic toxicities, which are common adverse events following CAR-T infusion. No grade ≥3 cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS) and no graft-versus-host disease (GVHD) were observed. No treatment-related deaths or study discontinuation due to AE. As of May 10, 2026, with a median follow-up of 6.97 months, 6 patients maintained responses. All 8 patients were evaluable for efficacy. Six patients achieved stringent complete response (sCR) (n=5) or very good partial response (VGPR) (n=1) following the initial 4.5×10⁸ infusion. One R/R MM patient achieved partial response (PR) and ongoing response at Month 10 after retreatment with 4.5×10⁸, following failure of initial 3.0×10⁸ infusion. One overweight pPCL patient (102 kg) who received reduced intensity lymphodepletion progressed after the initial 4.5×10⁸ infusion, but achieved sCR following retreatment with full-dose lymphodepletion and 6.0×10⁸. By disease subtype analysis, both pPCL patients achieved sCR. Among the 6 MM patients, 4 achieved sCR, 1 achieved VGPR, and 1 achieved PR. All patients achieved MRD negativity at a sensitivity of 10⁻⁶ at 4 weeks after the effective infusion. Pharmacokinetic results from the 8 infused patients demonstrated robust and persistent cell expansion, with median Cmax of 100,078 copies/µg gDNA and median Tmax of 10.5 days. Data for CT1190B in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma A total of 13 patients (10 with large B-cell lymphoma [LBCL] and 3 with follicular lymphoma [FL]) received CT1190B infusion, with 1, 2, 4, and 6 patients dosed with 1.5×10⁸, 3.0×10⁸, 4.5×10⁸, and 6.0×10⁸ cells, respectively. All patients were heavily pretreated, with a median of 3 prior lines of therapy (range 2-7). The majority of grade ≥3 adverse events were hematological toxicities, of which most recovered within 28 days. No grade ≥3 infections occurred. CRS was observed in 8 patients (7 grade 1-2, 1 grade 3) and all recovered within 11 days. ICANS occurred in 2 patients (one grade ≥3 resolving, one grade 1 resolved). No study discontinuations or deaths due to adverse events. As of May 11, 2026, 12 patients were evaluable for efficacy. The objective response rate (ORR) was 91.7% (11/12) with complete response (CR) rate of 66.7% (8/12), including: 1 partial response (PR) and 1 CR at 3.0×10⁸; 1 PR and 3 CR at 4.5×10⁸; 1 PR and 4 CR at 6.0×10⁸. All 3 FL patients achieved CR. All 7 LBCL patients under lymphodepletion regimen A achieved response with a CR rate of 71.4%. Notably, responses were observed even in patients with prior CAR T-cell or bispecific antibody therapy exposure, and all patients treated at intermediate or higher doses (≥3.0×10⁸) achieved response. With a median follow-up of 6.62 months, 7 out of 11 responders maintained ongoing response. CAR T-cell expansion was observed across intermediate and higher doses with a median Tmax of 10 days. At the highest dose level (6.0×10⁸ cells), the median Cmax (reaching 10⁵) and AUC0-t (reaching 6×10⁵) of CT1190B far exceeded those of currently approved autologous CAR‑T products (Cmax: 10³–10⁴; AUC 0-t: 10⁴–2×10⁵). About CT0596 CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen's proprietary THANK-u Plus® platform. It is currently being evaluated in IITs for R/R MM or PCL. CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. The Company plans to initiate Phase Ib clinical trials for R/R MM and primary PCL in 2026. About CT1190B CT1190B is a CD19/CD20-targeted allogeneic CAR-T cell therapy developed based on CARsgen's THANK-u Plus® platform. IITs for R/R B-NHL are ongoing. The Company plans to initiate Phase Ib clinical trials for R/R B-NHL in 2026. 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 21% more press release views with Request a Demo

SHANGHAI, March 6, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, has announced its 2025 Annual Results. Business Highlights Continue Reading CARsgen Pipeline Cash and cash equivalents were around RMB1,123 million as of December 31, 2025. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,000 million. The net loss for the year ended December 31, 2025 was RMB103 million, representing a decrease of approximately 87% compared to the year ended December 31, 2024. In light of operational factors such as the changes in operating cash flow, we expect to have adequate cash into the 2030. During 2025, CARsgen has received a total of 218 confirmed orders of zevor-cel from its commercialization partner Huadong Medicine. In December 2025, zevor-cel has been included in China's Commercial Health Insurance Innovative Drug Catalogue (2025). The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) and granted Priority Review for satri-cel. The results of satri-cel confirmatory Phase II trial in China have been simultaneously 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 independently developed the lentiviral-based CARvivo™ platform for creating in vivo CAR T-cell products. CARsgen entered into strategic cooperation agreements with a key platform enterprise in Jinshan District, Shanghai to establish an advanced commercial manufacturing base for CAR T-cell products. Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "2025 is a pivotal year for CARsgen Therapeutics. As we enter the phase of substantial value realization in commercialization, zevor-cel has demonstrated an excellent market performance. Meanwhile, satri-cel, the world's first CAR-T candidate for solid tumors that has entered the NDA review process, is expected to be approved in the first half of 2026 and initiate commercialization. With its strong clinical value and broad market potential, it is poised to become the company's next core growth driver. In 2025, the company has shifted its focus to the field of allogeneic CAR-T cell therapies. We believe that off-the-shelf cell therapies capable of large-scale production are crucial for serving a broad patient population and opening a new chapter for the industry. Leveraging our proprietary THANK-uCAR® and THANK-u Plus™ platforms, we are advancing multiple allogeneic CAR-T candidates, with encouraging preliminary clinical data demonstrating promising efficacy and a favorable safety profile. Additionally, we are also advancing in vivo CAR T-cell therapies based on our proprietary CARvivo™ platform. Looking ahead, we will continue to unite our efforts, move forward with determination, and execute our strategic plans with rigorous precision, bringing renewed hope to patients worldwide." Financial Highlights CARsgen's revenue was around RMB125.7 million for the year ended December 31, 2025 mainly from zevor-cel, autologous BCMA CAR T-cell product in which the primary revenue of zevor-cel was calculated on the basis of ex-works price, rather than on the basis of 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 RMB80 million for the year ended December 31, 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. Our net loss was around RMB103 million for the year ended December 31, 2025, representing a decrease of around RMB695 million from around RMB798 million for the year ended December 31, 2024. Cash and cash equivalents were around RMB1,123 million as of December 31, 2025, representing a decrease of around RMB356 million from around RMB1,479 million as of December 31, 2024. The decrease was mainly due to research and development expenses, administrative expenses and investment of capital expenditure. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,000 million. In light of operational factors such as the changes in operating cash flow, we expect to have adequate cash into the 2030. Zevor-cel demonstrates rapids 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 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 218 confirmed orders from Huadong Medicine. In December, 2025, zevor-cel was included in China's Commercial Health Insurance Innovative Drug Catalogue (2025). We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage. The updated long-term follow-up results of Phase I clinical trial of CT053 have been published in Blood Advances. The updated data of Phase II clinical trial, involving 102 patients with a median follow-up of 20 months, were published in Experimental Hematology & Oncology. Zevor-cel demonstrates manageable safety profile while eliciting deep and durable responses in R/R MM patients. CARsgen entered into a collaboration with Dispatch Bio, to conduct a Phase I trial in China, planned to begin in 2026. The trial will evaluate DISP-11, an investigational therapy leveraging Dispatch's first-in class Flare platform – including DV-10, the company's novel tumor-specific virus – and zevor-cel, in patients suffering from solid tumors. Satri-cel is about to be commercialized in China Satricabtagene autoleucel (satri-cel, R&D code: CT041) is an autologous humanized CAR T-cell product against Claudin18.2. In China, satri-cel was granted Breakthrough Therapy Designation (BTD) in March 2025 and Priority Review in May 2025 by the CDE. In June 2025, the CDE of NMPA of China has accepted the 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 CAR T-cell therapy for the treatment of solid tumors that has advanced to NDA stage worldwide. It is expected to be approved and start commercialization in the first half of 2026. 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. The research results of the Phase Ib registrational clinical trial of satri-cel for PC adjuvant therapy in China (NCT05911217) has been presented as a poster session at European Society for Medical Oncology (ESMO) Congress in October 2025. The trial represents the world's first proof-of-concept (POC) study exploring CAR T-cell therapy for the adjuvant treatment of solid tumors. In addition, an investigator-initiated trial (IIT) for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (NCT06857786), and an IIT for satri-cel as a sequential therapy following first-line treatment in patients with advanced G/GEJA (NCT07179484) have been conducted in China. Multiple allogeneic CAR-T product candidates in development CARsgen has been advancing differentiated allogeneic CAR T-cell products utilizing the CARsgen's proprietary THANK-uCAR® and THANK-u Plus™ platform. THANK-u Plus™ platform, as an enhanced version of THANK-uCAR®, was developed to address the potential impact of NKG2A expression levels on therapeutic efficacy of the allogeneic CAR T-cells. CT0596 is a BCMA-targeting allogeneic CAR T-cell product candidate deploying our THANK-u Plus™ technology. The IITs are ongoing in China to evaluate the safety and efficacy of CT0596 for the treatment of R/R MM and PCL. Two IND applications for R/R MM and primary plasma cell leukemia (pPCL) separately were submitted to the NMPA in December 2025 and have been accepted. Phase Ib registration trials in China are planned to be initiated in 2026. Preliminary results of an IIT have been presented at the 67th ASH in December 2025. CT1190B (KJ-C2219) is an allogeneic CAR T-cell product candidate targeting CD19/CD20 deploying our THANK-u Plus™ technology, for hematologic malignancies and autoimmune diseases. The IITs have been initiated for R/R B-NHL, and for systemic lupus erythematosus (SLE) and systemic sclerosis (SSc), separately. It is expected to obtain IND approval from the NMPA for B-cell malignancies in 2026. Phase Ib registration study is planned to be initiated in 2026 in China. In addition, multiple products against different targets are currently under development: KJ-C2320 against CD38 for acute myeloid leukemia (AML); KJ-C2526 against NKG2DL for AML, other malignancies and senescence; CT1390B against CLL1 for AML; KJ-C2527 against Claudin18.2 for gastric cancer. On February 25, 2025, CARsgen has entered into the agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership), to jointly invest in UCARsgen Biotech Limited. In vivo CAR-T product candidates in development Apart from CAR T-cell products manufactured via in vitro gene editing, CARsgen is also developing in vivo CAR T-cell products. CARsgen's proprietary lentiviral-based CARvivo™ platform demonstrates excellent T cell transduction and targeting specificity. KJ-C2529 is an in vivo CAR T-cell product candidate against CD19/CD20 deploying our CARvivo™ platform for the treatment of B-cell lymphoma. An IIT is expected to be initiated in 2026 for the treatment of R/R B-NHL. Expand CAR-T commercial manufacturing base CARsgen is actively preparing for capacity expansion, enhancing the manufacturing capabilities for CAR T-cell therapies that meet international standards to support the commercialization of multiple products and strengthen its global competitiveness. On February 12, 2026, CARsgen, through its indirectly wholly-owned subsidiary CARsgen Diagnostics Co., Ltd., signed strategic cooperation agreements with Shanghai Jingong Enterprise Development Co., Ltd., which is a key platform enterprise in the Bay Area High-Tech Zone of Jinshan District, Shanghai. With a total investment amount not exceeding RMB370 million, CARsgen will establish an advanced commercial manufacturing base for CAR T-cell products in Jinshan District, Shanghai. No significant upfront capital expenditure is required from CARsgen, effectively preserving valuable cash flow for core research and development as well as market expansion. In addition, the repurchase mechanism ensures CARsgen can fully acquire asset control after long-term operation, maintaining production stability and enhancing the flexibility of asset layout. 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 21% more press release views with Request a Demo