drugset / Trial / NCT04643574
NeoTIL in Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
Single center, single arm pilot trial to test the feasibility, safety and efficacy of NeoTIL-ACT combined with low-dose irradiation (LDI) in patients with advanced, recurrent or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by LDI, and then ACT utilizing ex vivo expanded TIL, enriched for tumor antigen specificity (NeoTIL), in combination with high dose Interleukin-2 (IL-2) (optional, depending on patient's tolerance). LDI will be administered once to metastatic lesions using tomotherapy.
Timeline
- Start
- 2021-03-09
- Primary completion
- 2027-11
- Completion
- 2027-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NeoTIL | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | IL-2 | Protein / enzyme biologic | — | — |