GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

NCT05352542 | Terminated Phase 1

• 1 other identifier: GPC3-targeting Study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (5)

• Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

  An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment

  Minimum 2 years after CART infusion (Day 1)

• Dose-limiting toxicity (DLT) rate

  Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.

  Minimum 2 years after CART infusion (Day 1)

• Recommended Phase 2 dose (RP2D) finding

  RP2D established through ATD+BOIN design

  30 days after CART infusion (Day 1)

• CAR positive T cells

  CAR positive T cells after CART infusion

  Minimum 2 years after CART infusion (Day 1)

• CAR transgene levels in peripheral blood

  CAR transgene levels in peripheral blood after CART infusion

  Minimum 2 years after CART infusion (Day 1)

Secondary Outcomes (7)

• Overall response rate (ORR)

  Minimum 2 years after CART infusion (Day 1)

• Disease control rate (DCR)

  Minimum 2 years after CART infusion (Day 1)

• Duration of Response(DoR)

  Minimum 2 years after CART infusion (Day 1)

• Time to Response (TTR)

  Minimum 2 years after CART infusion (Day 1)

• Progress Free Survival (PFS)

  2 years after CART infusion (Day 1)

Study Arms (1)

GPC3 Targeting CART Cells

EXPERIMENTAL

Each subject will receive GPC3 Targeting CART cells

Biological: GPC3 Targeting CART Cells

Interventions

GPC3 Targeting CART Cells BIOLOGICAL

before treatment with GPC3 Targeting CART cells, subjects will receive a conditioning regimen

GPC3 Targeting CART Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;
• Age 18-75 years;
• Patients diagnosed as advanced hepatocellular carcinoma (HCC) histopathologically or cytologically; Progression or intolerance after previous standard systemic therapy;
• GPC3 is detected positive by immunohistochemistry (IHC);
• Child-Pugh score ≤ 7;
• At least one assessable tumor lesion;
• ECOG score: 0-1;
• Expected survival ≥ 3 months;
• Clinical laboratory values meet screening visit criteria

You may not qualify if:

• Previous CAR-T cell, TCR-T cell or other cell therapies or therapeutic tumor vaccination directed at any target;
• Any previous GPC3 targeted therapy;
• Prior antitumor therapy with insufficient washout period;
• Brain metastases with central nervous system symptoms;
• Pregnant or lactating women
• HCV-Ab or/and HIV-Ab positive; active syphilis;
• Severe underlying diseases
• Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.

Sponsors & Collaborators

• jianming xu: lead

Study Sites (2)

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Leading Site Principal Investigator

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 29, 2022
• Study Start: May 19, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)