Not Yet RecruitingPhase 2

BCMA/CD3 BsAb Therapy for POEMS Syndrome

China10 participantsStarted 2025-08-10

Plain-language summary

This is a prospective, single-arm, investigator-initiated clinical trial evaluating the safety and efficacy of a BCMA/CD3 bispecific antibody (CM336) in patients with POEMS syndrome.

Who can participate

Age range18 Years – 78 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years.
✓. Diagnosed with POEMS syndrome according to the 2025 Chinese Expert Consensus.
✓. Deemed suitable for BCMA/CD3 bispecific antibody therapy by the investigator.
✓. ECOG performance status 0-2.
✓. Adequate organ function.
✓. Provided written informed consent.

Exclusion criteria

✕. Not meeting the diagnostic criteria for POEMS syndrome, including:
✕. History of prior anti-plasma cell therapy, such as melphalan, cyclophosphamide, proteasome inhibitors, IMiDs, monoclonal antibodies, CAR-T, or bispecific antibodies (except:
✕. Immunosuppressants used for autoimmune neuropathy;
✕. Bisphosphonates used for bone disease;
✕. Topical or low-dose steroids ≤20 mg/day for rheumatic disease).
✕. Investigator judges the patient unsuitable for BCMA/CD3 bispecific therapy (e.g., severe cardiopulmonary dysfunction).
✕. Known allergy or intolerance to BCMA/CD3 bispecific antibody or any component.

What they're measuring

Incidence of Adverse Events and Overall Response Rate (ORR)

Timeframe: Up to 12 months after treatment initiation

Trial details

NCT IDNCT07115654

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Gang An, MD

13502181109 angang@ihcams.ac.cn

View on ClinicalTrials.gov More POEMS Syndrome trials