To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma

The primary objective of this Phase 1 clinical trial is to evaluate the feasibility and tolerability of a novel generation of gene-modified tumor infiltrating lymphocytes (TILs) in a cohort of 10 patients aged 18-75 diagnosed with unresectable or metastatic melanoma. TILs will undergo transduction with the Interleukin-7 (IL-7) gene, for IL-7 production upon antigen engagement. Participants will undergo: * screening * tumor operation following autologous TIL production (incl. transduction) - takes approximately 4-6 weeks * admission for lymphodepleting chemotherapy (Cyclophosphamide and Fluda

Trial Details

NCT ID
NCT06204991
Phase
PHASE1
Sponsor
Inge Marie Svane
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • ADP-TILIL7
  • Cyclophosphamide
  • Fludarabine Phosphate
  • Proleukin
Locations (sample)
  • Herlev, Denmark|55.72366,12.43998
  • Herlev, Denmark|55.72366,12.43998

Key Eligibility Criteria

  • All the criteria listed in the following need to be met before patient inclusion.
  • Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV).
  • Progressive disease after standard treatment with PD-1 check-point inhibition or combination of aforementioned with CTLA-4 check-point inhibition.
  • Age: 18 - 75 years at time of signed Informed consent.

For full eligibility, visit ClinicalTrials.gov.

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