TrialBridgeNCT07927842
BCMA/GPRC5D Dual-Target CAR-T Cell Immunotherapy for Relapsed/Refractory Multiple Myeloma
Not Yet Recruiting · Phase 1 · Liping Dou · registry updated 2026-11-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a single-center, open-label, single-arm, investigator-initiated clinical study to evaluate the safety, tolerability, and preliminary efficacy of SL4903, a BCMA/GPRC5D dual-target autologous CAR-T cell injection, in patients with relapsed or refractory multiple myeloma (R/R MM) whose clonal plasma cells are positive for BCMA and/or GPRC5D. After leukapheresis, participants receive lymphodepleting conditioning (fludarabine 30 mg/m\^2/day plus cyclophosphamide 500 mg/m\^2/day on Days -5 to -3), followed by a single intravenous infusion of SL4903 at a dose of 1×10\^6 CAR-positive cells/kg; bridging therapy (e.g., immunomodulatory drugs or anti-CD38 monoclonal antibody) is permitted between leukapheresis and conditioning at the investigator's discretion. Treatment-emergent adverse events, including cytokine release syndrome (CRS), neurotoxicity, hematologic toxicity, and organ toxicity, will be assessed within 3 months after infusion....
Inclusion
- Voluntarily agrees to participate in the study (signed informed consent form by the participant or a legally authorized representative), and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
- Clinically diagnosed relapsed/refractory multiple myeloma, meeting both of the following:
- Clonal plasma cells positive for BCMA and/or GPRC5D by flow cytometry or immunohistochemistry.
- Prior treatment with at least 3 drug classes (proteasome inhibitors \[PIs\], immunomodulatory drugs \[IMiDs\], and an anti-CD38 monoclonal antibody), with best response less than partial response (PR) or disease progression after achieving PR or better.
- Male or female participants aged 18 to 75 years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion
- The patient has severe cardiac dysfunction, or left ventricular ejection fraction (LVEF) \<50%, or a history within the 12 months prior to enrollment of myocardial infarction, coronary angioplasty or coronary stent implantation, unstable angina, clinically significant arrhythmia, or other severe cardiovascular diseases.
- A history of severe pulmonary disease with impaired lung function.
- Concurrent progressive malignancy other than multiple myeloma.
- Severe active infection that cannot be effectively controlled.
- Severe autoimmune disease or congenital immunodeficiency.
- Active hepatitis, defined as hepatitis B virus DNA (HBV-DNA) or hepatitis C virus RNA (HCV-RNA) levels above the lower limit of detection, or human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection.