Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06204991 | To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma | PHASE1 | RECRUITING | 10 | — | — | Apr 1, 2025 | Apr 1, 2028 | Aug 24, 2025 | 2 | Denmark |
Fraction of subjects experiencing grade \>/= 3 AE
Measured by the number of subjects who undergo surgery and succesfully undergo ADP-TILIL7-infusion
| Arm | Type | Description |
|---|---|---|
| Tumor-infiltrating lymphocytes genemodified with IL-7 gene for IL-7 production upon Ag engagement | EXPERIMENTAL | Tumor-infiltrating lymphocytes grown ex-vivo from resected tumor tissue and reapplied to the patient via an intravenous infusion. Drug: Cyclophosphamide: 2 doses (69 mg/kg) prior to infusion Drug: Fludarabinephosphat 5 doses (25 mg/m2, max. 50 mg) prior to infusion Drug: Proleukin 600.000 IU/kg/dose IL-2 a maximum of 6 doses |
| Name | Type | Description |
|---|---|---|
| ADP-TILIL7 | BIOLOGICAL | Autologous tumor infiltrating lymphocytes genemodified (by a lentiviral vector) to produce IL-7 upon antigen engagement |
| Cyclophosphamide | DRUG | Lymphodepleting Chemotherapy |
| Fludarabine Phosphate | DRUG | Lymphodepleting Chemotherapy |
| Proleukin | DRUG | IL-2 |
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 aforement...