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

Sponsor
Zhejiang University
Study ID
NCT05155189
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 21, 2022
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
May 31, 2041

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: C-CAR031
    Autologous C-CAR031 administered by intravenous (IV) infusion
  • Experimental: C-CAR031 combined with Lenvatinb
    Autologous C-CAR031 combination with Lenvatinib
  • Experimental: C-CAR031 combined with Regorafenib
    Autologous C-CAR031 combination with Regorafenib
  • Experimental: C-CAR031 combined with Durvalumab
    Autologous C-CAR031 combination with Durvalumab

Primary Outcome Measure

TEAEs [ Time Frame: start pretreatment to 12 months ]

Central Contacts

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