Human BCMA Targeted T Cells Injection(BCMA CAR-T)for Subjects With R/R MM

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHrain Biotechnology Co., Ltd.

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

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hrain Biotechnology Co., Ltd.

Lead sponsor

Shanghai Changzheng Hospital

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator