GCC19CART / Innovative Cellular Therapeutics - LARVOL DELTA

A phase 1 dose-escalation study of GCC19CART: A novel CAR T-cell therapy for metastatic colorectal cancer in the United States. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05319314 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

CAR T-Cell Therapy • Metastases • P1 data • Colorectal Cancer • Oncology • Solid Tumor

A phase 1 dose-escalation study of GCC19CART: A novel CAR T-cell therapy for metastatic colorectal cancer in the United States. (ASCO-GI 2025) - P1 | "Eligible subjects underwent leukapheresis, lymphodepleting chemotherapy (fludarabine 30mg/m2 and cyclophosphamide 300mg/m2 on day-3), and then infusion of a single dose GCC19CART...Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 2/9 subjects (Grade 2: 1/9 [11.1%] or Grade 3: 1/9 [11.1%]) and resolved rapidly with corticosteroid and dasatinib treatment... Preliminary results indicate that GCC19CART exhibits significant clinical activity in patients with refractory mCRC. Adverse events were related to GCC19CART mechanism and in line with what has been observed with other CAR T-cell products. Strategies to further optimize the management of treatment-related diarrhea are currently being implemented."

CAR T-Cell Therapy • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

GCC19CART Demonstrates Preliminary Antitumor Activity in Refractory mCRC (OncLive) - P1 | N=30 | CARAPIA-1 (NCT05319314) | Sponsor: Innovative Cellular Therapeutics Inc. | "The administration of GCC19CART...led to clinical antitumor activity in patients with refractory...mCRC, according to preliminary findings from an ongoing trial phase 1 (NCT05319314) presented at the 2025 Gastrointestinal Cancers Symposium. Results revealed that at dose level 1 (1 x 10⁶ cells/kg), evaluable patients (n = 4) experienced an overall response rate (ORR) of 25.0%, including 1 patient achieving a confirmed partial response (PR) and 2 others showing partial metabolic responses with stable disease (SD). At dose level 2 (2 x 10⁶ cells/kg; n = 5), the ORR was 80.0%, with 1 patient achieving a pathological complete response and 3 others reaching PR....The ORR in the overall population between both dose levels (n = 9) was 56%. The disease control rate was 75% for dose level 1, 80% for dose level 2, and 78% for both dose levels."

P1 data • Colorectal Cancer

Chimeric Antigen Receptor T Cells Targeting CD19 and GCC in Metastatic Colorectal Cancer: A Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - "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. Chinese Clinical Trial Registry: ChiCTR2000040645."

CAR T-Cell Therapy • Clinical • Journal • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Innovative Cellular Therapeutics Announces the Publication of Groundbreaking GCC19CART Study to Treat mCRC in JAMA Oncology (GlobeNewswire) - P1 | N=15 | ChiCTR2000040645 | "The published results highlight the successful use of GCC19CART therapy in heavily pretreated patients with mCRC, achieving an objective response rate (ORR) of 57% at 2X106 CAR-T cells/kg and median overall survival (mOS) of 22.8 months....At the first dose, 1X106 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, 2X106 CAR-T cells/kg dose level, 4 out of 5 patients achieved Partial Response (PR), resulting in an ORR of 80%."

P1 data • Colorectal Cancer • Oncology • Solid Tumor

A phase 1 dose escalation study of a novel coupled CAR T cell therapy, GCC19CART, for patients with metastatic colorectal cancer. (ASCO 2024) - P1 | "Eligible subjects underwent leukapheresis, lymphodepleting chemotherapy with a single dose of fludarabine 30mg/m2 and cyclophosphamide 300mg/m2, and infusion of GCC19CART. 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."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Oncology • Solid Tumor

Metastatic Colorectal Cancer CAR-T Therapy GCC19CART Demonstrates Safety and Clinical Activity in US Patients (CGTLive) - P1 | N=30 | CARAPIA-1 (NCT05319314) | Sponsor: Innovative Cellular Therapeutics Inc. | "GCC19CART...has demonstrated safety and clinical activity among patients with refractory metastatic colorectal cancer being treated in the phase 1 CARAPIA-1 clinical trial (NCT05319314). The data were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 to June 4, in Chicago, Illinois...The group includes 4 patients who were treated at dose level 1 (1x106 cells/kg, DL1) and 1 patient who was treated at dose level 2 (2x106 cells/kg, DL2), all of whom had reached the end of the 30 day dose limiting toxicity timeframe. The overall response rate was 40%, with 2 of 5 patients having achieved a partial response to the CAR-T....In terms of safety, cytokine release syndrome (CRS) was reported in all 5 patients, with 2 patients (40%) having grade 1 cases of CRS and 3 patients (60%) having grade 2 cases of CRS."

Cytokine release syndrome • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

ASGCT | The objective response rate of CAR-T therapy for solid tumors increased by 30 times compared with the US standard treatment [Google translation] (Sohu.com) - P1 | N=30 | CARAPIA-1 (NCT05319314) | Sponsor: Innovative Cellular Therapeutics Inc. | "The company's research summary on GCC19CART , the leading therapy for solid tumors , was honored to be selected this time. ASGCT Annual Meeting. On the afternoon of May 8, local time, Dr. Victor Lu...attended on behalf of the company and presented the latest progress of the GCC19CART US clinical trial CARAPIA-1 in the form of an oral report...the objective efficacy of the GCC19CART low-dose group (1x10^6 CAR-T/kg) The response rate (ORR) was 15.4% (2/13), and the ORR of the mid-dose group (2x10^6 CAR-T/kg) was 50% (4/8)....The clinical trial of the low-dose group has been completed, and the clinical trial of the mid-dose group (2x10^6 CAR T/kg) is ongoing. As of April 18, 2024, 3 patients in the medium-dose group have completed reinfusion treatment, 2 patients have completed evaluation, and 1 patient has achieved PR."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase 1 Dose Escalation Study of a Novel Coupled CAR T Cell Therapy, GCC19CART, for Patients with Metastatic Colorectal Cancer (ASGCT 2024) - P1 | "Eligible subjects underwent 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. Preliminary results from the US study corroborate our finds from the Chinee trial, demonstrating that GCC19CART has meaningful clinical activity and an acceptable safety profile 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."

CAR T-Cell Therapy • Clinical • Metastases • P1 data • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Movement Disorders • Oncology • Solid Tumor

A phase 1 dose escalation study of a novel coupled CAR T cell therapy, GCC19CART, for patients with metastatic colorectal cancer (AACR 2024) - P1 | "Eligible subjects underwent 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. Preliminary results demonstrate that GCC19CART has meaningful clinical activity and an acceptable safety profile 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."

CAR T-Cell Therapy • Clinical • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A phase 1 dose escalation study of GCC19CART – A novel CoupledCAR® therapy for subjects with metastatic colorectal cancer (SITC 2023) - "CoupledCAR utilizes multiple vectors to make both solid tumor targeting CAR-T and CD19 CAR-T in a single manufacturing step...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...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 • IO biomarker • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

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 (GlobeNewswire) - P1 | N=30 | NCT05319314 | Sponsor: Innovative Cellular Therapeutics Inc. | "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%))."

Cytokine release syndrome • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A phase I dose escalation study of GCC19CART: A novel CoupledCAR therapy for subjects with metastatic colorectal cancer (ESMO 2023) - "CoupledCAR utilizes multiple vectors to make both solid tumor targeting CAR-T and CD19 CAR-T in a single manufacturing step...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: Dose 1 (1x106) or Dose 2 (2x106) CAR T-cells/kg...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 • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CART Therapy in GUCY2C-positive Digestive Tract Tumors (clinicaltrials.gov) - P1 | N=1 | Completed | Sponsor: Weijia Fang, MD | Recruiting ➔ Completed | N=10 ➔ 1

Enrollment change • Trial completion • Colorectal Cancer • Gastrointestinal Cancer • Oncology

A phase 1 dose escalation study of GCC19CART: A novel coupled CAR therapy for patients with metastatic colorectal cancer. (ASCO 2023) - "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. 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 • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Innovative Cellular Therapeutics (ICT) Presented Data at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting (GlobeNewswire) - P1 | N=30 | CARAPIA-1 (NCT05319314) | Sponsor: Innovative Cellular Therapeutics Inc. | "Innovative Cellular Therapeutics, Inc..;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....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."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase 1 Dose Escalation Study of GCC19CART - A Novel CoupledCAR Therapy for Subjects with Metastatic Colorectal Cancer (ASGCT 2023) - "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. 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 • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • CD19

Innovative Cellular Therapeutics (ICT) Presented Updated Data at the American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - P1 | N=30 | NCT05319314 | Sponsor : Innovative Cellular Therapeutics Inc. | "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....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."

P1 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A phase 1 dose escalation study of GCC19CART - a novel CoupledCAR therapy for subjects with metastatic colorectal cancer (AACR 2023) - "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. preliminary data show 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 under a cleared IND is expected to enroll patients from mid-2022."

Clinical • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor • CD19

A Phase 1 Dose Escalation Study of GCC19CART a Novel CoupledCAR Therapy for Subjects With Metastatic Colorectal Cancer (SITC 2022) - "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: 1x10 6 or 2x10 6 CAR T-cells/kg. This trial is ongoing and updated data will be presented. A United States based Phase 1 trial of GCC19CART is anticipated for mid-2022."

Clinical • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor • CD19

Novel CoupledCAR technology for treating colorectal cancer (ESMO 2022) - "CoupledCAR utilizes multiple vectors to make both solid tumor targeting CAR-T and CD19 CAR-T in a single manufacturing step...Eligible subjects undergo leukapheresis, a single dose of lymphodepleting chemotherapy (fludarabine 30mg/m 2 and cyclophosphamide 300mg/m 2 ) 3 days prior to infusion, and then administration of a single infusion of GCC19CART at one of two preassigned doses: Dose 1 (1x10 6 ) or Dose 2 (2x10 6 ) CAR T-cells/kg...It was well tolerated and toxicity was manageable. A United States based phase I trial of GCC19CART is anticipated to begin enrolling subjects in mid-2022."

Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD19

Innovative Cellular Therapeutics (ICT) Announces First Patient Enrolled for the Company’s Phase I Trial of GCC19CART for Relapsed/Refractory Metastatic Colorectal Cancer (GlobeNewswire) - "Innovative Cellular Therapeutics, Inc...announced that the first patient has been enrolled in its Phase I trial of GCC19CART for Relapsed/Refractory Metastatic Colorectal Cancer (R/R mCRC). The study (NCT05319314) is an open-label, single arm, multicenter Phase 1 dose-escalation clinical trial evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of GCC19CART in patients with relapsed or refractory metastatic colorectal cancer (R/R mCRC) in the U.S."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CARAPIA-1: GCC19CART for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Innovative Cellular Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD19

A phase 1 dose-escalation study of GCC19 CART a novel coupled CAR therapy for subjects with metastatic colorectal cancer. (ASCO 2022) - "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. GCC19CART demonstrated 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 United States based Phase 1 trial of GCC19CART is anticipated for mid-2022."

Clinical • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Inflammation • Oncology • Solid Tumor • CD19

Innovative Cellular Therapeutics (ICT) Announces Presentation at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Innovative Cellular Therapeutics, Inc...announced the acceptance of an abstract for poster presentation at the upcoming 2022 ASCO Annual meeting in Chicago, IL from June 3-7, 2022. ICT will provide updated data on 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."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology