OncoMatch/Clinical Trials/NCT06204991
To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma
Is NCT06204991 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ADP-TILIL7 and Cyclophosphamide for melanoma stage iii.
Treatment: ADP-TILIL7 · Cyclophosphamide · Fludarabine Phosphate · Proleukin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
Progressive disease after standard treatment with PD-1 check-point inhibition
Cannot have received: T-cell therapy
Prior T-cell therapy, including gene therapy using an integrating vector
Lab requirements
Blood counts
ANC ≥ 1,500/µl; Leucocyte count ≥ lower normal limit; Platelets ≥ 100,000/µl and <700,000/µl; Hemoglobin ≥ 6.0 mmol/l; Sufficient coagulation: APPT<40 and INR<1.5
Kidney function
eGFR > 70 ml/min (selected cases with eGFR < 70 ml/min may be included with reduced chemotherapy dose)
Liver function
S-bilirubin ≤ 1.5x ULN (≤2.5x ULN with liver metastasis); ASAT/ALAT ≤ 2.5x ULN (≤5.0x ULN with liver metastasis); Alkaline phosphatase ≤ 5x ULN; Lactate dehydrogenase ≤ 5x ULN
Cardiac function
LVEF ≥50% by TTE or MUGA
Sufficient organ function, including: ANC ≥ 1.500 /µl; Leucocyte count ≥ lower normal limit; Platelets ≥ 100.000 /µl and <700.000 /µl; Hemoglobin ≥ 6.0 mmol/l; eGFR > 70 ml/min*; S-bilirubin ≤ 1.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 2.5 × ULN); ASAT/ALAT ≤ 2.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 5.0 × ULN); Alkaline phosphatase ≤ 5 times upper normal limit; Lactate dehydrogenase ≤ 5 times upper normal limit; Sufficient coagulation: APPT<40 and INR<1.5. LVEF assessment with documented LVEF ≥50% by either TTE or MUGA.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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