NCT06204991 To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma
| NCT ID | NCT06204991 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Inge Marie Svane |
| Condition | Melanoma Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-03-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * All the criteria listed in the following need to be met before patient inclusion. 1. Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV). 2. Progressive disease after standard treatment with PD-1 check-point inhibition or combination of aforementioned with CTLA-4 check-point inhibition. 3. Age: 18 - 75 years at time of signed Informed consent. 4. ECOG performance status of ≤ 1 (Appendix 2). 5. Is fit for tumor resection and has at least one lesion (\> 1 cm3) available for surgical resection for manufacture of TIL. 6. At least one measurable parameter in accordance with RECIST 1.1 -criteria (excluding lesion to be resected). 7. LVEF assessment with documented LVEF ≥50% by either TTE (transthoracic echocardiography) or MUGA (multigated acquisition scan). 8. Sufficient organ function, including: * Absolute neutrophil count (ANC) ≥ 1.500 /µl * Leucocyte count ≥ lower normal limit * Platelets ≥ 100.000 /µl and \<700.000 /µl * Hemoglobin ≥ 6.0
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