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.
Single group
Dual CD19/BCMA CAR-T
Other interventionNovel CD19/BCMA Dual-Targeted CAR-T Cell Therapy
The incidence of adverse events
The incidence of adverse events and abnormal laboratory findings that are "possibly" or "definitely" related to the study treatment, occurring at any time from the start of monitoring until Week 24, including dose-limiting toxicity (DLT).
Primary implant endpoint
The survival time of CAR-T cells in vivo is defined as the "engraftment endpoint." PCR detection of CAR-T cell DNA sequences begins 24 hours post-infusion at scheduled follow-up time points and continues until any two consecutive tests yield negative results, at which point the "engraftment endpoint" is recorded.
complete response (CR), very good partial response (VGPR), and partial response (PR)
According to the International Myeloma Working Group (IMWG) unified response criteria for multiple myeloma
Overall survival
Overall survival
Progression-free survival
Progression-free survival
Detection and quantification of CD19/BCMA CAR-T cells
Detection and quantification of CD19/BCMA CAR-T cells in blood, bone marrow, and/or tumor tissue
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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
