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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-78
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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 criteria

Qualifiers

≥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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BCMA/CD3 bispecific antibody (CM336)

Treatment groups

21 Participants
are divided into 1 treatment group