Chimeric Antigen Receptor T Cells (CART) Therapy in GUYC2C postive Digestive system tumors, include colorectal cancer, gastric cancer, liver cancer, pancreatic cancer, adenocarcinoma of esophagus, cancer of the esophagogastric junction.
Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted therapy in patients with advanced gastrointestinal tumors.

Start Date01 Mar 2021

Sponsor / Collaborator

Innovative Cellular Therapeutics Co., Ltd.

[+1]

NCT04652219 / CompletedEarly Phase 1IIT

Clinical Study on the Safety and Efficacy of CART Cells in the Treatment of Advanced GUCY2C-positive Digestive Tract Tumors

Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted therapy in patients with advanced gastrointestinal tumors.

Start Date10 Oct 2020

Sponsor / Collaborator

Zhejiang University

[+1]

NCT03118180 / Unknown statusPhase 1/2IIT

The Safety and Efficacy Evaluation of CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma

A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma.

Start Date05 Apr 2017

Sponsor / Collaborator

Zhejiang University

[+1]

100 Clinical Results associated with Innovative Cellular Therapeutics Co., Ltd.

0 Patents (Medical) associated with Innovative Cellular Therapeutics Co., Ltd.

Literatures (Medical) associated with Innovative Cellular Therapeutics Co., Ltd.

19 Sep 2024·JAMA oncology

Chimeric Antigen Receptor T Cells Targeting CD19 and GCC in Metastatic Colorectal Cancer: A Nonrandomized Clinical Trial.

Article

Author: Tang, Haiyang ; Lu, Victor X ; Han, Guiting ; Wang, Yizhuo ; Yang, Hang ; Zhao, Lingling ; Chen, Dongqi ; Pu, Chengfei ; Rowinsky, Eric K ; Niu, Chao ; Li, Wei ; Kennedy, Eugene ; Cui, Jiuwei ; Xiao, Lei ; Jiang, Xianyang ; Chen, Naifei ; Liang, Tingting ; Wang, Chang ; Wang, Wensheng ; Wu, Zhao ; Cui, Guozhen ; Jia, Beibei ; Huang, Xi ; Wang, Yiming ; Zhu, Ruihong

ImportanceChimeric antigen receptor (CAR) T-cell therapy (CART) has transformed the treatment landscape of hematologic cancer, but has negligible effects for adult solid cancers. In this trial, an autologous CAR T-cell product demonstrated antitumor activity in heavily pretreated patients with metastatic colorectal cancer (mCRC).ObjectiveTo evaluate the safety and efficacy of guanylate cyclase-C (GCC19) CART in participants with metastatic colorectal cancer (mCRC).Design, Setting, and ParticipantsThis single-arm, nonrandomized, phase 1 trial was conducted at the First Hospital of Jilin University from December 3, 2020, to April 13, 2022. Data analysis was conducted from May 2022 to April 2024. Adults with relapsed and refractory mCRC expressing GCC were treated with GCC19CART, a mixture of autologous CAR T cells transduced with lentiviral vectors expressing genes that encode either CD-19 CAR or GCC CAR.Main Outcomes and MeasuresSafety and tolerability of CAR T-cell therapy targeting GCC in patients with mCRC without therapeutic options is capable of conferring a reasonable likeliness of clinical benefit. Other outcomes included objective response rate, progression-free survival, overall survival, and immune activation.ResultsOf 15 patients 9 (60%) were women, and the median (range) age was 44 (33-61) years. Treatment with GCC19CART was associated with the development of cytokine release syndrome and diarrhea in most patients, all of which were self-limited and manageable. The objective response rate was 40%, with a partial response in 2 of 8 and 4 of 7 patients treated with either 1 × 106 cells/kg or 2 × 106 cells/kg. Median overall survival was 22.8 months (95% CI, 13.4-26.1) at data cutoff; the median progress-free survival was 6.0 months in the high dose level group (95% CI, 3.0 to not available).Conclusions and RelevanceThe results of this nonrandomized clinical trial suggest that GCC19CART was safe and tolerable in heavily pretreated patients with mCRC and is the first CAR T-cell therapy known to produce objective clinical activity in refractory cancer. Given the paucity of effective therapeutics developed for colorectal cancer in recent decades, the observation that CD-19 CART target engagement can robustly induce GCC19CART target engagement sufficient to produce objective activity may serve as a foundation to develop effective cellular therapy in mCRC and other solid cancers.Trial RegistrationChinese Clinical Trial Registry: ChiCTR2000040645.

01 Jun 2024·Journal of Clinical Oncology

A phase 1 dose escalation study of a novel coupled CAR T cell therapy, GCC19CART, for patients with metastatic colorectal cancer.

Author: Keenan, Bridget P. ; Ng, Kimmie ; Surana, Rishi ; Lu, Lucy ; Lieu, Christopher Hanyoung ; Schlechter, Benjamin L. ; Fakih, Marwan ; Chen, Dongqi ; Rowinsky, Eric Keith ; Xiao, Lei ; Lu, Victor

e15572 Background: GCC19CART is a multitargeted CAR-T cell therapy designed to overcome the limitations of conventional CAR-T cells in solid malignancies by pairing a solid tumor targeting CAR with additional CD19-targeting CARs. This addition is meant to amplify proliferation, activation, and persistence of the CAR-T cells with a goal to overcome the inherent resistance of solid tumors to CAR-T cells. Guanylate cyclase-C (GCC) has been reported to be expressed in over 80% of colorectal cancers with normal expression largely restricted to the luminal side of the GI tract, making it an appealing target for CAR-T cell therapy. A Phase 1 investigator-initiated clinical trial in China reported preliminary results with an ORR of 15.4% (2/13), mOS of 13.3 months in dose level 1 (1x106 CAR-T cells/kg) and 50% (4/8), mOS of 26.1 months in dose level 2 (2x106 CAR-T cells/kg). Common adverse events included cytokine release syndrome (CRS), diarrhea/colitis, and immune effector cell-associated neurotoxicity syndrome (ICANS). Methods: A phase 1 study in the United States was initiated in August, 2022, for patients with refractory metastatic colorectal cancer. As of a data cutoff of December 31, 2023, with a prespecified analysis after the DLT window for the first patient treated at dose level 2, 5 subjects have been reinfused: 4 in dose level 1 and 1 in dose level 2. Subjects were screened for GCC expression. Over 95% of participants screened positive, so this requirement was removed. Eligible subjects underwent leukapheresis, lymphodepleting chemotherapy with a single dose of fludarabine 30mg/m2 and cyclophosphamide 300mg/m2, and infusion of GCC19CART. Responses were assessed by RECIST v1.1 by site investigator and an independent third-party imaging review. Results: Five subjects have been treated, 4 in dose level 1 (1x106 cells/kg) and 1 in dose level 2 (2x106 cells/kg), and have completed the 30 day DLT period. The most common CAR-T related adverse events were CRS in 5/5 subjects (grade 1: 2/5 (40%) and grade 2: 3/5 (60%)), diarrhea in 4/5 subjects (grade 1: 1/5 (20%), grade 2: 2/5 (40%), and grade 3: 1/5 (20%)), and ICANS (grade 2: 1/5 (20%)). All adverse events resolved with therapy. The ORR was 40% (2/5) by independent review: 2 subjects demonstrated a partial response however 1 additional subject had partial metabolic response on PET/CT with stable disease. Progressive disease was seen in 2 participants by RECIST 1.1, but 1 has a falling tumor marker suggesting tumor flare. Conclusions: Preliminary results demonstrate that GCC19CART has an acceptable safety profile and meaningful clinical activity in refractory metastatic colorectal cancer. This trial is ongoing and updated data will be presented, including from patients treated at dose level 2 (2x106 CAR-T cells/kg). Clinical trial information: NCT05319314 .

01 Jun 2023·Journal of Clinical Oncology

A phase 1 dose escalation study of GCC19CART: A novel coupled CAR therapy for patients with metastatic colorectal cancer.

Author: Song, Yongping ; Chen, Naifei ; Liang, Tingting ; Wang, Chang ; Bie, Jun ; Yang, Zhenzhou ; Wang, Yizhuo ; Li, Ning ; Xiao, Lei ; Lu, Victor ; Huang, Yusheng ; Cui, Jiuwei ; Zhu, Ruihong ; Pu, Chengfei ; Zhao, Lingling ; Wu, Zhao ; Li, Xun ; Jia, Beibei ; Chen, Dongqi ; Luo, Su-xia

3547 Background: GCC19CART, the first clinical candidate from the CoupledCAR solid tumor platform, is designed to overcome the limitations of conventional CAR T-cells in solid tumor malignancies by pairing solid tumor CAR T-cells with CD19 targeting CAR T-cells to amplify the proliferation and activation of the solid tumor CAR T component. GCC19CART targets guanylate cyclase-C (GCC), which is expressed in the metastatic lesions of 70%-80% of subjects with colorectal cancers and largely restricted to the intestinal tract. A Phase 1 investigator-initiated clinical trial is underway in China for patients with relapsed or refractory metastatic colorectal cancer who have received at least 2 prior lines of therapy. As of a data cutoff on Jan 28, 2023 21 subjects have been enrolled in 2 dose escalation groups at 5 hospitals in China. Methods: Subjects are screened for GCC expression by immunohistochemistry. Eligible subjects undergo leukapheresis, a single dose of lymphodepleting chemotherapy (fludarabine 30mg/m2 and cyclophosphamide 300mg/m2) 3 days prior to infusion, and then administration of a single infusion of GCC19CART at one of two preassigned doses: 1x106 or 2x106 CAR T-cells/kg. All responses were confirmed by an independent third-party imaging contract research organization. Results: 13 subjects have been enrolled to dose level 1 (1x106 cells/kg) and 8 subjects have been enrolled to dose level 2 (2x106 cells/kg). The most common adverse events were cytokine release syndrome (CRS) in 21/21 subjects (Grade 1 19/21 (90.48%) or Grade 2 2/21 (9.52%)) and diarrhea in 21/21 subjects (Grade 1 6/21 (28.57%) Grade 2 5/21 (23.81%) Grade 3 9/21 (42.86%) or Grade 4 1/21 (4.76%)). All patients with grade 3 and higher side effects were well managed. Immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in 2/21 (9.52%) subjects at Grade 3 or 4 and resolved with corticosteroids. The combined overall response rate (ORR) for both dose levels was 28.6% (6/21). For dose level 1, overall response rate (ORR) was 15.4% (2/13). Two subjects demonstrated a partial response (PR) while 3 additional subjects had partial metabolic response (PMR) on PET/CT with stable disease (SD) or progressive disease (PD) per RECIST 1.1. For dose level 2, The ORR was 50% (4/8). 4 subjects demonstrated a PR and 2 additional subjects had PMR on PET/CT with SD per RECIST 1.1.The median PFS was 1.9 months in the dose 1 group and 6.3 months in the dose 2 group. The median overall survival was 13.3 months in the dose 1 group and 18.3 months in the dose 2 group. Conclusions: Preliminary results demonstrate that GCC19CART has meaningful dose-dependent clinical activity and an acceptable safety profile in relapsed or refractory metastatic colorectal cancer. This trial is ongoing and updated data will be presented. A Phase 1 trial of GCC19CART in the US has opened for accrual and is expected to enroll patients in mid-2022. Clinical trial information: ChiCTR2000040645 .

News (Medical) associated with Innovative Cellular Therapeutics Co., Ltd.

19 Sep 2024

·www.biospace.com

Innovative Cellular Therapeutics Announces the Publication of Groundbreaking GCC19CART™ Study to Treat mCRC in JAMA Oncology

ROCKVILLE, Md., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced that its groundbreaking study on GCC19CART TM therapy has been published in JAMA Oncology on September 19, 2024. The study represents a significant milestone in the field of CAR-T cell therapy for solid tumors, with particular focus on metastatic colorectal cancer (mCRC). The published results highlight the successful use of GCC19CART TM therapy in heavily pretreated patients with mCRC, achieving an objective response rate (ORR) of 57% at 2X10 6 CAR-T cells/kg and median overall survival (mOS) of 22.8 months. “To our best knowledge, this is the first report to show that CAR-T therapy can be effective in treating solid cancers as a single agent in adult solid tumor setting,” said Dr. Larry (Lei) Xiao, Co-founder and CEO of ICT. “This product is based on the CoupledCAR platform technology, which integrates multiple genes and sequentially activating their spatiotemporal expression. In contrast to other attempts of administering CAR-T cells directed against solid cancers, it enables CAR-T cells targeting solid cancers to expand and activate within the immune system without binding to antigens. These CAR-T cells are then efficiently traffic from the immune system to the solid tumor microenvironment outside the blood, achieving effective tumor cell killing. The expansion and activation of these solid cancer targeting CAR-T cells are independent of solid tumor antigens, demonstrating efficacy not only in metastatic colorectal cancer but also with potential for application in other types of tumors.” U.S. Data Adds Further Validation In parallel with these results, data from ICT’s ongoing phase 1 clinical trials in the U.S. also show encouraging progress. At the first dose, 1X10 6 CAR-T cells/kg dose level, 2 out of 4 patients achieved Partial Response (PR), resulting in an ORR of 50%. At the second dose, 2X10 6 CAR-T cells/kg dose level, 4 out of 5 patients achieved Partial Response (PR), resulting in an ORR of 80%. These findings, though preliminary, indicate that the treatment may exceed expectations in efficacy. Dr. Eric Rowinsky, ICT’s Chief Medical Officer, commented on the U.S. results: “Putting the ICT technology into prospective, the last three therapies approved in this setting has demonstrated ORRs ranging from 1-6%, indicating the potential of this treat to palliate patients with advanced disease and potentially make major impacts on the natural history of disease in early disease settings.” For more information, please refer to the full article in JAMA Oncology . About Innovative Cellular Therapeutics Innovative Cellular Therapeutics (ICT) is a private clinical-stage biotechnology company headquartered in Rockville, MD. ICT is focused on developing cellular immunotherapies for the treatment of solid tumors. The Company’s proprietary CoupledCAR ® technology platform is designed to overcome the unique challenges of treating solid tumors by enabling the expansion and activation of CAR-T cells independent of tumor antigens. ICT has achieved promising proof-of-concept clinical results in metastasis solid cancers, such as colorectal cancer and prostate cancer. In its ongoing phase 1 U.S. clinical trials, ICT has achieved an ORR of 80% in patients with metastatic colorectal cancer at the 2X10 6 CAR-T cells/kg dose level. These promising preliminary results highlight the potential of ICT’s technology to significantly impact the treatment of advanced disease. The Company is advancing a broad pipeline of CAR-T candidates targeting other solid tumors. For more information, please visit . Investor Relations Contacts: Innovative Cellular Therapeutics: ir@ictbioinc.com

Cell TherapyPhase 1ImmunotherapyClinical Result

31 Oct 2023

·www.globenewswire.com

Innovative Cellular Therapeutics (ICT) Presented Updated Data of the China-IRB Study of GCC19CART in Metastatic Colorectal Cancer at European Society for Medical Oncology (ESMO) Congress 2023

ROCKVILLE, Md., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain from October 20th to 24th. ICT presented updated data from its China-IRB study of GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in a poster presentation. Presentation details were as follows: A Phase 1 Dose Escalation Study of GCC19CART a Novel CoupledCAR® Therapy for Subjects with Metastatic Colorectal CancerAbstract: 4936Session Title: Colorectal cancer Date and Time: Sunday, October 22nd, 2023 at 12:00 to 13:00 CESTPresenter: Lucy Lu, MD, Chief Operations Officer of ICT This presentation highlights updated survival data from the 21 subjects who were enrolled in two dose escalation groups in IRB-approved studies in China. Of the 21 subjects who were enrolled on or before Dec 13, 2021, 13 subjects have been enrolled to dose level 1 (1x106 cells/kg) and 8 subjects have been enrolled to dose level 2 (2x106 cells/kg). The combined objective response rate (ORR) per RECIST 1.1 for both dose levels was 28.6% (6/21). For dose level 1, the ORR was 15.4% (2/13). For dose level 2, the ORR was 50% (4/8) and the rest of the 4 subjects had a best overall response of SD for a disease control rate (DCR) of 100% out to three months. The most common adverse events were cytokine release syndrome (CRS) in 20/21 subjects (Grade 1 19/21 (90.4%) or Grade 3 1/21 (4.8%)) and diarrhea in 20/21 subjects (Grade 1 6/21 (28.6%) Grade 2 5/21 (23.8%) Grade 3 9/21 (42.9%)). Neurotoxicity was observed in 2/21 (9.5%) subjects with one Grade 3 and one Grade 4 and resolved with corticosteroids. The median overall survival (OS) is approximately 13 months for patients in dose level 1. The median OS is approximately 24 months in dose level 2 with 4 of the 8 patients still alive. The Company’s Phase 1 study of GCC19CART is enrolling patients with R/R mCRC at multiple sites in the U.S. About Innovative Cellular Therapeutics Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company headquartered in Rockville, MD. ICT is focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and prostate cancer. The Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit www.ictbio.com. Investor Relations Contacts: Innovative Cellular Therapeutics:ir@ictbioinc.com

Phase 1Cell TherapyImmunotherapyClinical ResultASCO

24 May 2023

·www.globenewswire.com

Innovative Cellular Therapeutics (ICT) Presented Data at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting

ROCKVILLE, Md., May 24, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual meeting in Los Angeles, California. May 16-20, 2023. ICT presented GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in an oral presentation. Details for the oral presentation are as follows: A phase 1 dose escalation study of GCC19CART - a novel CoupledCAR therapy for subjects with metastatic colorectal cancerSession Type: Oral AbstractSession Title: Gene and Cell Therapy Trials in ProgressPresenter: Victor Lu, Ph.D, Chief Technology Officer, ICTDate and Time: May 20th, 2023, at 2:45 pm – 3:00 pm ET This presentation highlights data from the 21 patients who were enrolled in two dose escalation groups at 5 hospitals in China. Patients were followed for safety and preliminary evidence of efficacy. Thirteen patients were enrolled in dose level 1 (1x106 cells/kg) and 8 patients were enrolled in dose level 2 (2x106 cells/kg). For dose level 1, the objective response rate (ORR) per RECIST 1.1 was 15% (2/13). For dose level 2, The ORR per RECIST 1.1 was 50% (4/8). Median follow-up has exceeded 20 months. The most common adverse events were cytokine release syndrome (CRS) and diarrhea. Neurotoxicity was observed in 2 patients that was resolved with corticosteroids. Overall, GCC19CART demonstrated meaningful dose dependent clinical activity and an acceptable safety profile in patients with R/R mCRC. GCC19CART is now in clinical development in the U.S. and is on track to complete Phase 1 dose escalation clinical trial this year. About Innovative Cellular Therapeutics Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company headquartered in Rockville, MD. ICT is focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and prostate cancer. The Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit www.ictbio.com. Investor Relations Contacts:Innovative Cellular Therapeutics:ir@ictbioinc.com

Phase 1ImmunotherapyCell TherapyASCOAACR

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Drug(Targets)	Indications	Global Highest Phase

ICTCAR014 ( CD19 x PD-1 )	Refractory Aggressive Non-Hodgkin Lymphoma More	Phase 2 Clinical
Anti-thyroid stimulating hormone receptor chimeric antigen receptor T cell therapy(Innovative Cellular Therapeutics Co., Ltd.) ( TSHR )	Thyroid Cancer More	Phase 2
ICTCAR CRC(Innovative Cellular Therapeutics) ( GC-C )	Colorectal Cancer More	Phase 1
ICT077 ( CD19 x CLDN18.2 )	Stomach Cancer More	Phase 1
Anti-CD19 anti-MUC-1 CAR-T cell therapy (Innovative Cellular Therapeutics) ( CD19 x MUC1 )	Pancreatic Cancer More	Phase 1

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