Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
Recruiting
Phase 2Interventional Study
Solitary Bone PlasmacytomaPlasmacytoma of BonePlasma Cell Disorders
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 78
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
21 (estimated)
Sponsor
Institute of Hematology & Blood Diseases Hospital, China · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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 ha…
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.
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