Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinsk Scientific-Practical Center for Surgery, Transplantation and Hematology

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • anti BCMA CAR-T cells

Treatment groups

30 Participants
are divided into 1 treatment group