The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Beijing Tsinghua Chang Gung Hospital
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Percentage of adverse events
- Status
- Suspended
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of GPC3-CAR-T cells in patients with hepatocellular carcinoma.
Detailed Description
GPC3-CAR-T cells is a novel CAR-T cells which designed for the cell membrane protein Glypican-3. Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106, 3×106, 10×106 GPC3-CAR-T cells. Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28). The aim of this clinical trial is to evaluate the safety and efficacy of GPC3-CAR-T cells therapy in patients with hepatocellular carcinoma. The primary endpoint is the safety of CAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the CAR-T ratio and CAR gene copied number in PB, PFS, OS and DOR.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≧18years, gender unlimited.
- •Failure or intolerance after at least first-line treatment.
- •GPC3 positive(IHC)
- •Patients must have at least one target lesion available for evaluation.
- •BCLC B or C.
- •Child-Pugh grade A or B
- •ECOG is 0 or 1 (one week before enrollment.)
- •Estimated life expectancy ≥ 3 months.
- •Functioning of major organs are normal.
- •Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
Exclusion Criteria
- •There are uncontrollable active infections that need systemic treatment.
- •HIV antibody is positive or syphilis antibody is positive.
- •Pregnant or lactating women.
- •hepatic encephalopathy.
- •patients with organ failure:
- •Heart: NYHA heart function grade IV;
- •Liver: Grade C that achieves Child-Turcotte liver function grading;
- •Kidney: kidney failure and uremia;
- •Lung: symptoms of respiratory failure;
- •Brain: a person with a disability.
Outcomes
Primary Outcomes
Percentage of adverse events
Time Frame: 12months
Percentage of participants with adverse events.
Secondary Outcomes
- Objective Remission Rate(ORR)(12months)
- Proliferation ratio of CAR-T cells(12months)