drugset / Trial / NCT04389229
OVSTAR TIL Trial (OVarian Cancer Co-STimulatory Antigen Receptor TIL Trial)
Non-randomizedSequentialOpen-labelTreatment
Summary
An open label, multi-centre Phase 1/2a study of modified and unmodified autologous Tumour Infiltrating Lymphocytes (TIL) in patients with platinum-resistant ovarian cancer. The purpose of this phase I/II study is to evaluate the feasibility and safety of both standard unmodified TIL (UTIL-01) and TIL engineered to express the co-stimulatory receptor CoStAR (CoTIL-01) in platinum resistant ovarian cancer.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2023-03-31
- Completion
- 2025-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CoTIL-01 | Cell therapy | 2e+09 cells | — |
| Subject | UTIL-01 | Unknown | 5e+09 cells | — |
| Subject | UTIL-01 | Unknown | 5e+10 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | aldesleukin | Protein / enzyme biologic | 1.8e+07 iu | Subcutaneous |