Trials / Not Yet Recruiting
Not Yet RecruitingNCT07209813
GKL-006 Combined With TACE in Treatment of Unresectable Hepatocellular Carcinoma
A Phase Ⅱ, Multicenter, Parallel Comparison Clinical Study of GKL-006 Combined With TACE in Treatment of Unresectable Hepatocellular Carcinoma
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Beijing Gene Key Life Technology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-10-12
- Primary completion
- 2026-10-31
- Completion
- 2026-10-31
- First posted
- 2025-10-07
- Last updated
- 2025-10-07
Source: ClinicalTrials.gov record NCT07209813. Inclusion in this directory is not an endorsement.