This is a single-arm, open-label study to evaluate the efficacy and safety of CM336 combined with SOC therapy in patients with dynamically high-risk multiple myeloma.
Able to understand and voluntarily sign the informed consent form (ICF).
Aged ≥18 and ≤75 years.
Has measurable disease, meeting at least one of the following criteria: serum M-protein ≥5 g/L as measured by serum protein electrophoresis (SPEP); or, for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead; or urine M-protein ≥200 mg/24 hours; if neither serum nor urine M-protein meets the above criteria, involved serum free light chain (FLC) ≥100 mg/L in the presence of an abnormal serum FLC ratio (normal FLC ratio: 0.26 to 1.65).
Has received only one prior line of standard anti-myeloma therapy: standard induction therapy comprising at least two of the following: a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; followed by autologous hematopoietic stem cell transplantation or consolidation therapy, and standard maintenance therapy.
Primary plasma cell leukemia or secondary plasma cell leukemia.
Concurrent amyloidosis.
Concurrent central nervous system (CNS) involvement.
Prior treatment with BCMA-targeted therapy or CAR-T cell therapy.