This is a prospective, single-arm, single-center clinical trial designed to evaluate the safety and efficacy of radiation combined with a BCMA/CD3 bispecific antibody (CM336) in patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration.
≥18 years old
Histologically confirmed SBP with <10% clonal plasma cells in marrow
ECOG ≤ 2
No prior anti-myeloma therapy. Previous local radiotherapy for SBP is not an exclusion criterion.
Patients who have previously received anti-plasma cell therapy, including melphalan, cyclophosphamide, proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, bispecific antibodies, or chimeric antigen receptor T-cell (CAR-T) therapy.
Any condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
Single group
BCMA/CD3 bispecific antibody (CM336)
DrugPatients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336)
Safety and Tolerability
The primary outcome is to evaluate the safety and tolerability of the combination therapy. This includes the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0. Particular attention will be paid to cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Safety assessments will include laboratory parameters, vital signs, ECGs, and clinical symptoms.
Progression-Free Survival (PFS)
PFS is defined as the time from the start of treatment to the first documentation of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using IMWG criteria for progression from solitary plasmacytoma to multiple myeloma.
Multiple Myeloma Free Survival (MMFS)
MMFS is defined as the time from the start of treatment to the first documented diagnosis of multiple myeloma, based on IMWG criteria. Patients who do not progress to MM will be censored at the date of last follow-up. The diagnosis of MM will be confirmed by clinical, laboratory, and imaging criteria.
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