Finding studies
Finding studies
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Lead
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Locally manufactured second generation autologous CD19/22 CAR-T cells are used for immunotherapy. Protocol treatment includes leukapheresis in order to harvest T cells, lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one dual targeting CAR-T cells infusion. The Main research objectives of the Phase I: To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability. The Secondary research objectives of the Phase I: To explore the pharmacokinetics of CAR-T cells. The Main research objectives of the Phase II: Overall response rate, including complete response (CR) and partial response (PR) rates. The Secondary research objectives of the Phase II: Duration of response (DOR). Progression-free survival rates. Overall survival rates.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
