OncoMatch/Clinical Trials/NCT06961357
Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma
Is NCT06961357 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Cyclophosphamide and Fludarabine for melanoma.
Treatment: Cyclophosphamide · Fludarabine · Interleukin-2 · TIL Product — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care (anti-PD-1 therapy, anti-PD-L1 therapy, anti-CTLA-4 therapy, anti-LAG3 therapy, BRAF inhibitor, MEK inhibitor)
Participants must have failed, be refractory to, or unable to tolerate at least one line of standard of care in the opinion of the Investigator. For participants with cutaneous non-acral melanoma, standard of care therapy includes a PD-1/L1 or combination therapy with anti-PD1 and anti-CTLA4 or combination therapy of anti-PD1 and anti-LAG3 or if BRAF V600 activating mutation positive, a BRAF ± MEK inhibitor.
Cannot have received: live cell therapy
Exception: unless express written permission is provided by the clinical PI
Patients who received prior live cell therapy are excluded, unless express written permission is provided by the clinical PI.
Lab requirements
Blood counts
adequate organ and marrow function as defined within the protocol
Kidney function
adequate organ and marrow function as defined within the protocol
Liver function
adequate organ and marrow function as defined within the protocol
Cardiac function
Participants ≥65 years may need cardiology evaluation including cardiac stress test or coronary CT; LVEF > 45% and NYHA functional classification ≤ 1 required
Participants must have adequate organ and marrow function as defined within the protocol. ... Participants with a left ventricular ejection fraction (LVEF) ≤ 45% or New York Heart Association (NYHA) functional classification > 1 [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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