Actively Recruiting
Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-31
36
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed unresectable Stage III/IV or metastatic melanoma including cutaneous non-acral, acral, mucosal, or ocular types
- Failed, refractory to, or unable to tolerate at least one line of standard of care therapy including PD-1/L1 inhibitors or targeted therapies
- Completed any systemic therapy at least 4 weeks before lymphodepleting therapy with resolved adverse events to Grade 1 or less except alopecia and vitiligo
- Age 18 or older; patients 65 or older may require cardiac evaluation to confirm low risk
- ECOG performance status of 0 or 1
- Adequate organ and marrow function per protocol
- Seronegative for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody; if HCV antibody positive, must have negative HCV RNA
- Brain metastases are allowed if treated and stable for at least 4 weeks
- Negative pregnancy test for women of childbearing potential
- Both males and females of childbearing potential must agree to use birth control during the study and for specified periods after last drug administration
- Able to understand and sign informed consent
- At least one surgically accessible lesion for tumor harvest and one measurable lesion for response assessment
You will not qualify if you...
- History of ischemic heart disease or significant heart rhythm abnormalities without cardiology clearance
- Primary or acquired immunodeficiency disorders including HIV/AIDS
- Pregnant or breastfeeding women
- Current systemic steroid therapy above 10 mg prednisone equivalent or other immunosuppressive medications, except allowed replacement or stress doses
- History of severe allergic reaction to study drugs including cyclophosphamide, fludarabine, or IL-2
- Left ventricular ejection fraction 45% or less or NYHA functional class above 1
- Pulmonary function below specified thresholds unless stable with recent testing
- Medical conditions posing prohibitive risk for study participation or inability to complete treatments
- Active infections requiring antibiotics
- Active autoimmune diseases requiring systemic immunosuppressive treatment
- Prior live cell therapy without written permission from the principal investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
T
Tina Swartzlander
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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