drugset / Trial / NCT06236425
TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC
Phase 1
Active not recruiting
7 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Turnstone Biologics, Corp. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Phase 1b open-label study to evaluate the safety of selected TIL (TBio-4101) delivered after lymphodepleting chemotherapy and followed by intravenous (IV) bolus aldesleukin (IL-2) and pembrolizumab for patients with advanced HNSCC who have initially progressed on pembrolizumab or pembrolizumab/platinum chemotherapy.
Timeline
- Start
- 2024-03-14
- Primary completion
- 2025-04-09
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |
| Background | aldesleukin | Protein / enzyme biologic | — | Intravenous |
| Background | fluorouracil | Small molecule | — | — |