NCT07115667 Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
| NCT ID | NCT07115667 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Solitary Bone Plasmacytoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-12-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * ≥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 Criteria: 1. 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. 2. Any condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.