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DRUG:

GCC19CART

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Other names: gucy2c CAR-T cells, gucy2c cart cells, GCC19CART, ICTCAR-CRC
Company:
Innovative Cellular Therapeutics
Drug class:
GUCY2C-targeted CAR-T immunotherapy
over1year
CART Therapy in GUCY2C-positive Digestive Tract Tumors (clinicaltrials.gov)
P1, N=1, Completed, Weijia Fang, MD | Recruiting --> Completed | N=10 --> 1
Trial completion • Enrollment change • CAR T-Cell Therapy • Metastases
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GCC19CART
over1year
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 • P1 data • Metastases
|
CD19 (CD19 Molecule)
|
cyclophosphamide • fludarabine IV • GCC19CART
over1year
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 • P1 data • Metastases
|
CD19 (CD19 Molecule)
|
cyclophosphamide • fludarabine IV • GCC19CART
over2years
CARAPIA-1: GCC19CART for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
P1, N=30, Recruiting, Innovative Cellular Therapeutics Inc. | Not yet recruiting --> Recruiting
Enrollment open
|
CD19 (CD19 Molecule)
|
RAS wild-type
|
GCC19CART
over2years
A Phase 1 Dose Escalation Study of GCC19CART a Novel CoupledCAR® Therapy for Subjects with Metastatic Colorectal Cancer (ASGCT 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
|
CD19 (CD19 Molecule)
|
cyclophosphamide • fludarabine IV • GCC19CART
over2years
CARAPIA-1: GCC19CART for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
P1, N=30, Not yet recruiting, Innovative Cellular Therapeutics Inc.
New P1 trial
|
CD19 (CD19 Molecule) • IFNG (Interferon, gamma) • IL6 (Interleukin 6)
|
RAS wild-type
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GCC19CART