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 (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Melanoma
Disease stage
Required: Stage IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06204991 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior T-cell therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages