Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Enrolling; Phase 2

Conditions: Solitary Bone Plasmacytoma; Plasma Cell Disorders; Plasmacytoma of Bone

Treatments: Drug: BCMA/CD3 bispecific antibody (CM336)

Study type: Interventional

Funder types: Other

Identifiers

NCT07115667

IIT2025065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

BsAbs-treatment group

Experimental group

Description:

Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336)

Treatment:

Drug: BCMA/CD3 bispecific antibody (CM336)