A Study of GC101 TIL in Advanced Melanoma
NCT06703398 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2025-12-23
Summary
98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial,this trail is expected to be finished in 24 months
Conditions
Interventions
- BIOLOGICAL
-
GC101 TIL
Patients with advanced melanoma (excluding uveal melanoma) who have failed to PD-1 antibodies (if BRAF mutation is present, BRAF and MEK inhibitors have failed; if NRAS mutation is present, tunlametinib have failed) and are ineligible for resection
- DRUG
-
dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin
monotherapy or combination of dacarbazine, temozolomide, paclitaxel, platinum or cisplatun, and the chemotherapy's dosage could refer to the drug label or the relevant treatment guideline, the final decision is up to investigator
Sponsors & Collaborators
-
Shanghai Juncell Therapeutics
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
- 2024-12-20
- Primary Completion
- 2026-07-10
- Completion
- 2026-12-20
Countries
- China
Study Locations
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