Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma-A Single-center, Open-label, Single-arm Clinical Study
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
‣ 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:
• 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;
• Patients with multiple myeloma recurrence;
• ALT and AST \<3 times normal; bilirubin \<2.0mg / dl;
• Quality of survival score (KPS)\> 50%;
• The patient has no serious heart, liver, kidney and other diseases;
• Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;
⁃ Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;
⁃ Blood can be obtained intravenously, without other contraindications to leukapheresis;
⁃ Understand and voluntarily sign a written informed consent form.