A Prospective Single-Arm Clinical Trial of Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 78
Healthy Volunteers: f
View:
• ≥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
Locations
Other Locations
China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Gang An, MD
angang@ihcams.ac.cn
13502181109
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 21
Treatments
Experimental: BsAbs-treatment group
Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336)
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China