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
Male or female, aged ≥18 years.
Willing and able to give written, informed consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
Relapsed or refractory multiple myeloma according to IMWG criteria with two previous lines of therapy and resistance to proteosome inhibitors and immunomodulators.
Females who are pregnant or lactating.
History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).
Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
Single group
anti BCMA CAR-T cells
Biological/VaccineFollowing 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
Phase I. Safety
Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0, ICAHT and ASCTC.
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
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)
Phase II. Efficacy: Overall survival rates
Overall survival rates
Phase II. Progression-free survival rates
progression-free survival time
Phase II. Duration of response
duration of response
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