The purpose of this study is to estimate the safety and the efficacy of anti-CD19/22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 150 x 10⁶ CD19/CD22 CAR-T cells
State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Dermatology
Minsk, Belarus
Phase I. Safety
Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0
Time frame: 1 month post CAR-T cells infusion
Phase II. Overall response rate
Including complete response (CR) and partial response (PR) rates
Time frame: 3 months post CAR-T cells infusion
Phase I. CAR-T proliferation
To explore the pharmacokinetics of CAR-T cells: duration of expansion of CAR-T cells by flow cytometry, peak of expansion of CAR-T cells
Time frame: 3 months post CAR-T cells infusion
Phase II. Efficacy: Overall survival rates
Overall survival rates
Time frame: 12 months post CAR-T cells infusion
Phase II. Progression-free survival rates
progression-free survival time
Time frame: 12 months post CAR-T cells infusion
Phase II. Duration of response
duration of response
Time frame: 12 months post CAR-T cells infusion
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