drugset / Trial / NCT06961357
Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a phase I/II clinical trial of a single dose of CD40L-augmented TIL administered in patients with advanced melanoma (Cohort 1: Cutaneous acral melanoma, cutaneous non-acral melanoma, (n=26); Cohort 2: Mucosal melanoma, uveal melanoma, (n=10)). Patients will undergo an excision of a readily accessible tumor for preparation of TIL. Eligible patients with progressive disease after standard of care therapy will undergo lymphodepletion with cyclophosphamide and fludarabine followed by CD40L-augmented TIL and standard of care bolus dose interleukin-2 (short-course IL-2).
Timeline
- Start
- 2025-12-03
- Primary completion
- 2029-05
- Completion
- 2030-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TIL Product | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | aldesleukin | Protein / enzyme biologic | — | — |