This is a Single-center, open, single-arm clinical study, the goal of which was to evaluate the safety and efficacy of APRIL-BAFF-Bicephali CAR-T in relapsed and refractory multiple myeloma.The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase
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 co-stimulation (<5-fold);
Xuzhou Medical University
Lead sponsor
Yake Biotechnology Ltd.
Collaborator