drugset / Trial / NCT03992326
Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
Single center, single arm phase Ib trial to test the feasibility and safety of Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) combined with low-dose irradiation in patients with advanced or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by low dose irradiation (LDI), and then ACT utilizing ex vivo expanded TILs in combination with high dose IL-2 (optional, depending on patient's tolerance). LDI will be administered once to metastatic lesions using tomotherapy.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2021-03-05
- Completion
- 2021-03-05
Outcome
Outcome not reported
Stopped: “Internal competitive study that is open”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | — | — |