NCT06961357

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

Phase I/II Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (TIL) for Patients With Advanced Melanoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Part of lymphodepletion regimen.
DRUG	Fludarabine	Part of lymphodepletion regimen.
DRUG	Interleukin-2	Standard of care.
DRUG	TIL Product	Tumor-infiltrating lymphocytes are an investigational, personalized adoptive cell therapy.

Timeline

• Start date: 2025-12-03
• Primary completion: 2029-05-01
• Completion: 2030-05-01
• First posted: 2025-05-07
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study