Study 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).
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Request More InfoInterventions
CD73/AXL.HypoSti.CAR-T cellsBIOLOGICAL
Dose escalation: Dose1 (1×10\^6 cells/kg) , Dose 2(3×10\^6 cells/kg) ,Dose 3 (1×10\^7cells/kg); Dose expansion: RP2D.
Albumin-Bound PaclitaxelDRUG
Administered intravenously at dose of 100-200mg/m2 on day -5 .
CyclophosphamideDRUG
Administered intravenously at a total dose of 15-30mg/kg on day -3 and day -2 .
FludarabineDRUG
Administered intravenously at dose of 30mg/m2/d on day -3 and day -2.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Biotherapeutic Department, Chinese PLA General Hospital | Beijing | Beijing Municipality | China |