Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuzhou Medical University

About this trial

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Eligibility criteria

Qualifiers

Age is 18~70 years old;

Expected survival period of>12 weeks;

Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;

Patients with refractory multiple myeloma;

Disqualifiers

Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;

Infectious diseases (such as HIV, active tuberculosis, etc.);

Active hepatitis B or hepatitis C infection;

Feasibility assessment screening demonstrated <10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (<5-fold);

Trial design

Treatments tested in this trial

  • anti-FcRL5 CAR-T

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators