GKL-006 Combined With TACE in Treatment of Unresectable Hepatocellular Carcinoma
NCT07209813 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-10-07
Summary
This is a Phase II, open-label, randomized, multicenter study to evaluate the efficacy and safety of GKL-006 combine with TACE in adult patients with unresectable Hepatocellular carcinoma.
Conditions
Interventions
- BIOLOGICAL
-
GKL-006
GKL-006(3.0±0.9)×108 iNKT cells/m2 IV single infusion on Day 1 of each 14-day cycle for up to 11 cycles (≈6 month) in the absence of disease progression or unacceptable toxicity.
Sponsors & Collaborators
-
Beijing Gene Key Life Technology Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-12
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
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