RecruitingPhase 1NCT06204991

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

Phase 1 Study to Evaluate the Safety and Efficacy of TILs Transduced With IL-7 (ADP-TILIL7) in Patients With Locally Advanced or Metastatic Melanoma

Sponsor

Inge Marie Svane

Enrollment

10 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma Melanoma Stage IV Melanoma Stage III

Summary

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 Fludarabine phosphate), TIL infusion and high-dose IL-2 infusions for a maximum of 6 doses * Following treatment, patients will undergo systematic and regularly planned assessments, encompassing clinical evaluation, biochemistry analyses, and PET/CT scans. This thorough follow-up regimen will be continued until any of the following events occur: progressive disease, withdrawal from study, or end of study, which spans a duration of 15 years for trials involving genetically modified organisms.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests ADP-TILIL7 — a treatment that takes immune cells (called TILs) from a patient's own tumor, grows them in the lab with a molecule called IL-7, and infuses them back to fight cancer — for people with advanced melanoma (skin cancer) that stopped responding to standard immunotherapy. **You may be eligible if...** - You have inoperable or metastatic melanoma (stage IIIC or IV) - Your cancer progressed after treatment with PD-1 immunotherapy (such as pembrolizumab or nivolumab), with or without CTLA-4 therapy - You are between 18 and 75 years old - You have a tumor large enough (over 1 cm³) that can be surgically removed to make the TIL treatment - You have at least one other measurable tumor site remaining after the removal - Your heart function is adequate (ejection fraction of 50% or more) **You may NOT be eligible if...** - You are not fit enough for surgery to remove tumor tissue - You do not have a measurable tumor site outside the one to be resected - Your general health is poor (ECOG above 1) - You have serious heart, liver, or organ function issues Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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