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.
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;
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);
Single group
anti-FcRL5 CAR-T
Druganti-FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10\^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy.
Adverse events
Adverse events assessed according to NCI-CTCAE v5.0
overall response rate (ORR)
Assessment of ORR at Month 6, 12, 18 and 24
complete response (CR)
Assessment of CR at Month 6, 12, 18 and 24
Overall survival (OS)
Assessment of OS at Month 6, 12, 18 and 24
Event-free survival (EFS)
Assessment of EFS at Month 6, 12, 18 and 24
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