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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04052334 | Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma | PHASE1 | COMPLETED | 9 | — | — | Sep 27, 2019 | Jun 16, 2023 | Feb 20, 2026 | 1 | United States |
Participants able to safely tolerate preparatory lymphodepletion, infusion of tumor-infiltrating lymphocytes (TIL) and subsequent IL-2, as measured by adverse events and serious adverse events.
| Arm | Type | Description |
|---|---|---|
| Infusion of Tumor-infiltrating lymphocyte | EXPERIMENTAL | Participants will undergo tumor resection from which the tumor infiltrating lymphocyte (TIL) product will be generated. All participants will receive nonmyeloablative lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T-cell persistence and effectiveness in vivo. Cyclophosphamide will be administered at 60 mg/kg/day IV in 250 mL normal saline (NS). Fludarabine will then be infused at 25 mg/m\^2 intravenous piggyback (IVPB). All participants will receive not less than 10\^9, and up to 1x10\^12 T cells in ≥250 mL NS as an inpatient by intravenously (IV). Eight (8) to sixteen (16) hours after completing the T cell infusion, all participants will receive high-dose interleukin-2 (IL-2) on an inpatient basis at the standard dose of 600 000 IU/kg as an intravenous bolus over an approximate 15-minute period every 8 to 16 hours for up to 15 doses on days 1 to 5, as tolerated. |
| Name | Type | Description |
|---|---|---|
| TIL | DRUG | Participants will receive an infusion of Tumor-infiltrating lymphocytes (TIL) after tumor resection and TIL product is generated. |
| Interleukin-2 | DRUG | Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously (IV) bolus (about 15 minutes) every 8 to 16 hours for up to 15 doses, beginning approximately 8 to 16 hours after T-cell infusion. |
| Fludarabine | DRUG | Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 30 minutes for 5 days, prior to T-Cell infusion |
| Cyclophosphamide | DRUG | Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL normal saline (NS) over approximately 2 hours, 7 days prior to T-Cell infusion |
Inclusion Criteria: * Participants must fulfill all of the following criteria to be eligible for the study at the time of tumor resection and initiation of TIL expansion. * Stated willingness to comply with all study procedures and availability for the duration of the study * Participants must have...