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