The mail purpose of this study is to estimate the safety and the efficacy of anti-BCMA CAR- T cell immunotherapy for adults with relapsed or refractory multiple myeloma
Locally manufactured second generation autologous humanized anti-BCMA cells are used for immunotherapy. Protocol treatment includes leukapheresis in order to harvest T cells, lymphodepleting conditioning (fludarabine 30 mg/m2+ cyclophosphamide 300 mg/2(days -5-3)) followed by one anti (day 0) BCMA CAR-T cell infusion. The Main research objectives of the Phase I: To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, p arkinsonism 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 partial response (PR), very good partial response (VGPR), complete response (CR) and stringent complete response(sCR) 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
30
Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 250 x 10⁶ anti BCMA CAR-T cells
State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology
Minsk, Belarus
RECRUITINGPhase I. Safety
Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0, ICAHT and ASCTC.
Time frame: 1 month post CAR-T cells infusion
Phase II. Overall response rate
partial response (PR), very good partial response (VGPR), complete response (CR) and stringent complete response (sCR) rates according to IMVG criteria
Time frame: 12 months post CAR-T cells infusion
Phase I. duration of expansion of CAR-T cells
To explore the pharmacokinetics of CAR-T cells: \- duration of expansion of CAR-T cells by flow cytometry - duration of cell detection in peripheral blood (days)
Time frame: 12 months post CAR-T cells infusion
Phase II. Efficacy: Overall survival rates
Overall survival rates
Time frame: 3 years post CAR-T cells infusion
Phase II. Progression-free survival rates
progression-free survival time
Time frame: 3 years post CAR-T cells infusion
Phase II. Duration of response
duration of response
Time frame: 3 years post CAR-T cells infusion
Phase I. Peak of expansion of CAR-T cells
\- peak of expansion of CAR-T cells (cells/µl) - The day of maximum cell concentration in peripheral blood and bone marrow (day)
Time frame: 1 month post CAR-T cells infusion
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