drugset / Trial / NCT05681650
HER2 Targeted HypoSti.CAR-T Cells in HER2 Positive Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
Chimeric antigen receptor modified T (CAR-T) cell therapy still has multiple difficulties in solid tumors, such as absence of tumor specific antigens, complex immunosuppressive tumor microenvironment, and tumor heterogeneity. In this study, investigators developed a novel hypoxia-stimulated CAR expression system (HypoSti.CAR) that could enable CAR-T cell effectively expand and survive in hypoxic tumor microenvironment. After accomplishment of animal model verification, investigators conduct this clinical trial in order to assess the in vivo safety, feasibility and efficacy of HypoSti.CAR-HER2 T cells in HER2 antigen positive advanced solid tumors.
Timeline
- Start
- 2023-10-11
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HypoSti.CAR-HER2 T cells | Cell therapy | 1 cells/kg | — |
| Subject | HypoSti.CAR-HER2 T cells | Cell therapy | 3 cells/kg | — |
| Subject | HypoSti.CAR-HER2 T cells | Cell therapy | 6 cells/kg | — |
| Subject | HypoSti.CAR-HER2 T cells | Cell therapy | 10 cells/kg | — |
| Subject | HypoSti.CAR-HER2 T cells | Cell therapy | 15 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 15 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 30 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |