Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma
Trial Parameters
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: The set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (\<2 years) with existing therapies, as follows: 1. Age is 18\~70 years old; 2. Expected survival period of\>12 weeks; 3. Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging; 4. Patients with refractory multiple myeloma; 5. Patients with multiple myeloma recurrence; 6. ALT and AST \<3 times normal; bilirubin \<2.0mg / dl; 7. Quality of survival score (KPS)\> 50%; 8. The patient has no serious heart, liver, kidney and other diseases; 9. Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy; 10. Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions; 11. Blood can be obtained intravenously, without o