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.