Efficacy and Safety Study of Anti-FcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma
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.
‣ 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.