drugset / Trial / NCT05628883
Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma
Phase 1
Completed
17 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Turnstone Biologics, Corp. · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes \[TIL\]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or metastatic melanoma.
Timeline
- Start
- 2022-11-22
- Primary completion
- 2024-12-03
- Completion
- 2025-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | 600000 iu/kg | Intravenous |