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CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection

NCT06560827 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-19

No results posted yet for this study

Summary

A Single-arm, Open-label, Multicenter, Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of CT011 Autologous CAR-T Cells in Patients with Hepatocellular Carcinoma at Risk of Recurrence after Surgical Resection.

Conditions

Interventions

BIOLOGICAL

CT011 CAR-GPC3 T Cells Injection

The dose selection for this trial was mainly based on the preliminary safety and efficacy results of CT011-HCC-01 trial in subjects with advanced HCC, in which 3 and 5 subjects in the 2.5 × 108 cell and 5.0 × 108 cell dose groups, respectively, completed a single infusion of CT011. The results showed that the two dose groups of CT011 were generally well tolerated in HCC subjects who failed to standard treatment, with controllable safety, and showed preliminary anti-tumor efficacy.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • CARsgen Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jia fan · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-10-08
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06560827 on ClinicalTrials.gov