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

NCT06641453 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-16

No results posted yet for this study

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.

Conditions

  • Hepatocellular Carcinoma (HCC)

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.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Yangbin Zhao, Ph.D. · UTC Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2027-11-15
Completion
2028-11-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641453 on ClinicalTrials.gov