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);
Single group
APRIL-BAFF-Bicephali CAR-T cells
Other interventionPeripheral blood mononuclear cells were collected and subjected to CD3+T cells were enriched, transfected with APRIL-BAFF-Bicephali lentiviral vector, expanded by in vitro culture, and pretreated with clear lymphocytes using the FC protocol before infusion of APRIL-BAFF-Bicephali CAR-T cells.
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
Click on the lead sponsor to view all of their trials.
Xuzhou Medical University
Lead sponsor
Yake Biotechnology Ltd.
Collaborator
