About this trial
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection(BCMA CAR-T) Therapy for R/R MM.
Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
Eligibility criteria
Qualifiers
Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;
18 to 75 years old (including cut-off value),gender is not limited;
Expected survival > 12 weeks;
Previously diagnosed as multiple myeloma by the International Myeloma Working Group(IMWG) updated criteria;
Disqualifiers
Subjects have a history of central nervous system (CNS) diseases such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis; known or history of active central nervous system (CNS) involvement or presentation of multiple myeloma meninge/meningeal involvement;
Subjects with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis;
Accompanied by other uncontrolled malignancies, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;
Any uncontrollable active infection, including but not limited to active tuberculosis; fungal, bacterial, viral, or other infections that are uncontrollable or require systemic intravenous therapy are present or suspected within 14 days prior to enrollment;
Trial design
Treatments tested in this trial
- Human BCMA Targeted T Cells Injection
Treatment groups
Sponsors and collaborators
Hrain Biotechnology Co., Ltd.
Lead sponsor
Shanghai Changzheng Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator