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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06961357
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
May 7, 2025
Start date
Dec 3, 2025
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Phase I safety trial
    Participants will receive a single dose of CD40L-Augmented TIL. Toxicity will be evaluated at every 4 patients. The study may enroll 16-20 patients to reach 12 TIL safety evaluable patients.
  • Experimental: Cohort 1: Phase II efficacy trial
    If there are 2 responders or more, the trial will continue to enroll additional 14 patients in the 2nd stage.
  • Experimental: Cohort 2: Rare melanoma subtypes
    Cohort 2 will include n=10 patients with the rare melanoma histological subtypes of mucosal or uveal melanoma and will be used to assess feasibility and toxicity of the treatment in those rare melanoma subtypes.
  • Experimental: Cohort 3: TIL derived from core needle biopsy samples (all subtypes)
    Cohort 3 will include 12 patients with any subtype of melanoma whose TILs are manufactured from CNB specimens to assess the feasibility of this process.

Primary Outcome Measure

Phase I: Treatment Emergent Adverse Events (TEAE) [ Time Frame: Up to 28 days post TIL ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Lilit Karapetyan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Moffitt Cancer Center· Tampa, FL

Related Studies