Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BCMA/CD3 bispecific antibody (CM336).
- Who it may be relevant to
- Registry conditions: Solitary Bone Plasmacytoma, Plasmacytoma of Bone, Plasma Cell Disorders. Basic parameters: 18 years — 78 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Single-Arm Clinical Trial of Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
Overview
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.
Detailed description
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. SBP is a rare plasma cell malignancy with a high risk of progression to multiple myeloma (MM), particularly in patients with minimal bone marrow involvement.
Although radiotherapy is the standard treatment, it is often insufficient to eradicate clonal plasma cells and prevent progression in high-risk patients. CM336, a novel BCMA/CD3 bispecific antibody, has demonstrated promising activity in relapsed/refractory multiple myeloma. In this trial, eligible patients will receive radiotherapy followed by a 12-cycle limited treatment course of CM336, aiming to achieve deep clearance of residual malignant cells and reduce progression risk.
Interventions
- Drug BCMA/CD3 bispecific antibody (CM336)
Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336)
Primary outcome measures
- Safety and Tolerability [Time frame: From first dose through 28 days after last dose]
Secondary outcome measures (2)
- Progression-Free Survival (PFS) [Time frame: Up to 5 years]
- Multiple Myeloma Free Survival (MMFS) [Time frame: Up to 5 years]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07115667 · IIT2025065