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

NCT07115667 | Recruiting Phase 2

• 1 other identifier: IIT2025065
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Solitary Bone Plasmacytoma; Plasmacytoma of Bone; Plasma Cell Disorders

Keywords

solitary bone plasmacytoma; BCMA/CD3 bispecific antibody

Outcome Measures

Primary Outcomes (1)

• 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.

  From first dose through 28 days after last dose

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  Up to 5 years

• Multiple Myeloma Free Survival (MMFS)

  Up to 5 years

Study Arms (1)

BsAbs-treatment group

EXPERIMENTAL

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

Drug: BCMA/CD3 bispecific antibody (CM336)

Interventions

BCMA/CD3 bispecific antibody (CM336) DRUG

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

BsAbs-treatment group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Histologically confirmed SBP with \<10% clonal plasma cells in marrow
• ECOG ≤ 2
• Meets laboratory and imaging criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, 300020, China

RECRUITING

Central Study Contacts

Gang An, MD

CONTACT

13502181109; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

CN (1)