Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma

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).

NCT Number	NCT06961357
Lead Sponsor	H. Lee Moffitt Cancer Center and Research Institute
Conditions	Melanoma
Enrollment	36 participants
Start Date	2025-12-03
Primary Completion	2029-05 (estimated)
Study Completion	2030-05 (estimated)
Updated on ClinicalTrials.gov	2026-06-26