This study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma.
Relapsed/refractory multiple myeloma.
Confirmed by immunohistochemistry (IHC) or flow cytometry of bone marrow samples: plasma cell membrane expression of BCMA is positive (≥30%); no requirement for CD19 positivity rate. All sites must centrally submit bone marrow or plasmacytoma biopsy specimens to the lead site's pathology department or bone marrow/liquid specimens to KingMed Diagnostics (third-party laboratory) for BCMA expression verification.
Expected survival >12 weeks;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Received systemic therapy such as cyclophosphamide and fludarabine for lymphoma clearance within 2 weeks prior to enrollment or single-cell collection; prior CD19/BCMA CAR-T therapy; or cell or bispecific antibody therapy within 8 weeks prior to treatment.
Received bendamustine-containing regimens within 6 months prior to treatment.
Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV) positive status; any uncontrolled active infection, including active tuberculosis or Hepatitis B virus (HBV) DNA levels ≥1×10³ copies/mL.
Active infection within 72 hours prior to treatment initiation; subjects on ongoing prophylactic antibiotics, antifungals, or antivirals are not excluded provided there is no evidence of active infection and the antibiotics are not on the prohibited drug list.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Tongji Hospital
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
Jinhua Municipal Central Hospital
Collaborator