anti-cd19/bcma bispecific car-t cell therapy for r/r mm

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma Progression

Summary: the goal of this clinical trial is to study the feasibility and efficacy of anti-cd19/bcma bispecific chimeric antigen receptors (cars) t cell therapy for relapsed and refractory multiple myeloma.

primary objectives 1. to determine the feasibility ad safety of anti-cd19/bcma car-t cells in treating patients with bcma-positive multiple myeloma. secondary objectives 1. to access the efficacy of anti-cd19/bcma car-t cells in patients with multiple myeloma. 2. to determine in vivo dynamics and persistency of anti-cd19/bcma car-t cells.

Eligibility criteria:
inclusion criteria: * expected survival \> 12 weeks * diagnosis of multiple myeloma by imwg updated criteria (2014) * pathology demonstrated that bcma-poitive malignant plasma cells exited in bone marrow or plamacytoma * exited measurable lesions and in accordance with one of the following test indicators: serum m protein≥1 g/dl; urine m protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy * the criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: bortezomib), and immunomodulator (eg: revlimid), and have disease progression in the past 60 days * at least 90 days after stem cell transplantation * clinical performance status of ecog score 0-2 * creatinine≤2.0 mg/dl * bilirubin≤2.0 mg/dl * the alt/ast value is lower than 2.5-fold of normal value * accessible to intravenous injection, and no white blood cell collection contraindications * sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the ctl infusion. male partner should use a condom * 5mg/day dose of prednisone or other equivalent steroid hormone drugs (eg: dexamethasone) were not used for two weeks before apheresis and car-t infusion * able to understand and sign the informed consent document. exclusion criteria: * patients with symptoms of central nervous system * patients with second malignancies in addition to multiple myeloma * active hepatitis b or c, hiv infections * any other active diseases could affect the enrollment of this trial * long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment * patients with organ failure * women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy * a history of mental illness and poorly controlled * women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion * patients who are accounted by researchers to be not appropriate for this test * subjects suffering disease affects the understanding of informed consent or complying with study protocol