NCT05155189

A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031 in Advanced Hepatocellular Carcinoma

A Clinical Study to Evaluate Safety and Efficacy of C-CAR031 Armored CAR-T Cell Injection in Treatment of Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A study that aimed to assess the safety and anti-tumor activity of CCAR031 injection in unresectable HCC patients.

Detailed description

This study plans to enroll 4-36 patients to assess the safety of C-CAR031. Subjects who meet the eligibility criteria will receive a single dose of C-CAR031 injection, and will be followed up post-treatment for safety monitoring. This study will also enroll 6-36 patients to further explore the treatment modality of combination with Lenvatinib, Regorafenib or Durvalumab at explored safe and effective dose level(s) of C-CAR031 monotherapy in specific eligible advanced HCC patients to provide data support for the phase II study of CAR-T combination therapy. The follow-up period will be 12 months.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	C-CAR031	Targeting GPC3 armored CART cell injection (C-CAR031)
DRUG	Lenvatinib	Tyrosine kinase inhibitors
DRUG	Regorafenib (BAY 73-4506)	Tyrosine kinase inhibitors
DRUG	Durvalumab	Immune checkpoint inhibitors, ICIs

Timeline

• Start date: 2022-02-21
• Primary completion: 2026-05-01
• Completion: 2041-05-01
• First posted: 2021-12-13
• Last updated: 2026-01-21

Locations

2 sites across 1 country: China