This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D/CD3 bispecific antibody maintenance in transplant-eligible patients with ultra-high-risk multiple myeloma.
Age ≥ 18 years and ≤ 70 years.
Participants with documented newly-diagnosed multiple myeloma according to IMWG diagnostic criteria.
Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
Patients deemed eligible for high-dose chemotherapy with ASCT.
Active amyloidosis.
Central nervous system involvement.
Prior BCMA-targeted therapy or CAR-T therapy.
Active hepatitis B or hepatitis C virus infection.
Single group
Autologous Hematopoietic Stem Cell Transplantation
Procedure/SurgeryPatients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection.
BCMA CAR-T
Biological/VaccinePatients will receive BCMA CAR-T single dose (3.0 x 10\^6 cells /kg) infusion 3 days after ASCT.
GPRC5D/CD3 BiTEs
DrugPatients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion and continuing for at least 2 years
Sustained MRD-negative rate
Rate of patients achieving sustained MRD negativity for more than 12 months
MRD negativity rate
Rate of patients achieving MRD negativity
Safety and Tolerability
The incidence of treatment-emergent adverse events (TEAEs)
Complete response rate (CRR)
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria
Progression free survival (PFS)
Progression free survival is defined as the time from the date of diagnosis to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first
Overall survival (OS)
Overall survival is defined as the time from the date of diagnosis to the date of death due to any cause
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