RecruitingPhase 1Phase 2NCT06961357

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


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

36 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy called CD40L-augmented TIL — where a patient's own cancer-fighting immune cells (tumor-infiltrating lymphocytes, or TILs) are removed from a tumor, enhanced in the lab, and then infused back into the patient to fight advanced melanoma. This is for people whose melanoma has stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older and have advanced (unresectable stage III/IV) melanoma of any type — including skin, acral (hands/feet), mucosal, or eye melanoma - Your cancer has stopped responding to, or you cannot tolerate, at least one standard treatment (such as anti-PD-1 or BRAF/MEK inhibitors) - You have at least one tumor that can be surgically removed to collect immune cells, and at least one other measurable tumor to track treatment response - You are in good general health (ECOG 0 or 1) - You are willing to use reliable birth control during and after the study **You may NOT be eligible if...** - You have a history of significant heart disease (unless cleared by a cardiac specialist) - You have HIV/AIDS, a primary immune deficiency, or are on immunosuppressive medications (more than 10mg prednisone/day) - You are pregnant or breastfeeding - You have received prior live cell therapy (unless approved by the investigator) - You have active infections requiring antibiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Part of lymphodepletion regimen.

DRUGFludarabine

Part of lymphodepletion regimen.

DRUGInterleukin-2

Standard of care.

DRUGTIL Product

Tumor-infiltrating lymphocytes are an investigational, personalized adoptive cell therapy.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06961357


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