Study Summary
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 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 CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
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CD70-targeting 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
Drug: Albumin-bound paclitaxel
Administered intravenously at dose of 100-200mg/m2 on day -5;
Drug: Cyclophosphamide
Administered intravenously at dose of 15-30mg/kg on day -3 and day -2;
Drug: Fludarabine
Administered intravenously at dose of 30mg/m2 on day -3 and day -2;
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| China | Beijing | Iotherapeutic Department of Chinsese PLA Gereral Hospital | China |