Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
A Prospective Single-Arm Clinical Trial of Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
Institute of Hematology & Blood Diseases Hospital, China
21 participants
Aug 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- ≥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.
- Meets laboratory and imaging criteria
Exclusion Criteria2
- 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.
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Interventions
Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07115667