drugset / Trial / NCT06939270
CD73/AXL Targeted HypoSti.CAR-T Cells in CD73/AXL Positive Advanced/Metastatic Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of novel autologous hypoxia-activated CAR-T cell therapy targeting CD73 and AXL ( CD73/AXL.HypoSti.CAR-T) will be evaluated in patients with CD73/AXL antigen positive advanced/metastatic solid tumors. In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses Of CD73/AXL.HypoSti.CAR-T cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD73/AXL.HypoSti.CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Timeline
- Start
- 2025-05-01
- Primary completion
- 2027-05-01
- Completion
- 2028-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD73/AXL.HypoSti.CAR-T | Unknown | 1e+06 cells/kg | — |
| Subject | CD73/AXL.HypoSti.CAR-T | Unknown | 3e+06 cells/kg | — |
| Subject | CD73/AXL.HypoSti.CAR-T | Unknown | 1e+07 cells/kg | — |
| Background | Albumin-Bound Paclitaxel | Unknown | 100 mg/m2 | Intravenous |
| Background | Albumin-Bound Paclitaxel | Unknown | 200 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 15 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 30 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |