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NOT YET RECRUITING
NCT06641453
PHASE1/PHASE2

CAR-T Cell Therapy Targeting GPC3 in Patients with Advanced GPC3-Positive Hepatocellular Carcinoma

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

In this single-center, single-arm, prospective, open-label Phase 1/2 study, the safety and efficacy of autologous GPC3-targeted chimeric antigen receptor (CAR) T-cell therapy will be evaluated in patients with GPC3-positive advanced hepatocellular carcinoma. Phase 1 will involve the enrollment of six eligible patients to receive hepatic arterial infusion of GPC3-CAR T cells at a fixed dose of 1×10\^6 cells/kg, with or without a standard lymphodepleting conditioning regimen (fludarabine and cyclophosphamide). Based on the results, it will be assessed whether the FC lymphodepletion regimen is necessary. Subsequently an additional six patients will be enrolled in a "3+3" dose-escalation design to adjust the dose of GPC3-CAR T cells to achieve optimal safety and efficacy. The recommended Phase 2 dose (RP2D) will then be established. Phase 2 will involve the enrollment of 10-20 additional eligible patients to receive GPC3-CAR T cell therapy at the RP2D.

Official title: Phase I/II Study of CAR-T Cell Therapy Targeting GPC3 in Patients with Treated Advanced GPC3-Positive Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-15

Completion Date

2028-11-15

Last Updated

2024-10-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

GPC3-CART cells

Phase 1: Dose escalation (3+3): Dose 1 (1 × 10\^6 cells/kg) with or without FC regimen, Dose 2 (3 × 10\^6 cells/kg), Dose 3 (6 × 10\^6 cells/kg). Phase 2: Dose at RP2D.

DRUG

Fludarabine Phosphate for Injection

Administered intravenously at a dose of 20-30 mg/m²/day on days -5, -4, and -3.

DRUG

Cyclophosphamide for Injection

Administered intravenously at a dose of 300-500 mg/m²/day on days -5, -4, and -3.

Locations (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, China