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

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).

Trial Details

NCT ID
NCT06961357
Phase
PHASE1 / PHASE2
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Cyclophosphamide
  • Fludarabine
  • Interleukin-2
  • TIL Product
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Participants must have histologically confirmed, unresectable (Stage III/IV) or metastatic melanoma as follows: Cutaneous, non-acral, melanoma (inc…
  • 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. Fo…
  • Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 4 weeks from the start of lymphodepleting ther…
  • Participants must be ages ≥18. Additionally, participants who are ≥ 65 years of age may need to undergo a cardiology evaluation including a cardiac…

For full eligibility, visit ClinicalTrials.gov.

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