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BCMA/CD3 BsAb Therapy for POEMS Syndrome | Clinical Trials | Clareo Health

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BCMA/CD3 BsAb Therapy for POEMS Syndrome

A Prospective Single-Arm Clinical Trial of BCMA/CD3 BsAb Therapy for POEMS Syndrome

NCT07115654•Institute of Hematology & Blood Diseases Hospital, China

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.

Eligibility

Age

18 - 78 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Not meeting the diagnostic criteria for POEMS syndrome, including:
•* Chronic inflammatory demyelinating polyneuropathy (CIDP),
•* MGUS, multiple myeloma, amyloidosis, or other plasma cell disorders not meeting POEMS diagnostic criteria.
•2. History of prior anti-plasma cell therapy, such as melphalan, cyclophosphamide, proteasome inhibitors, IMiDs, monoclonal antibodies, CAR-T, or bispecific antibodies (except:
•1. Immunosuppressants used for autoimmune neuropathy;
•2. Bisphosphonates used for bone disease;
•3. Topical or low-dose steroids ≤20 mg/day for rheumatic disease).
•3. Investigator judges the patient unsuitable for BCMA/CD3 bispecific therapy (e.g., severe cardiopulmonary dysfunction).
•4. Known allergy or intolerance to BCMA/CD3 bispecific antibody or any component.

Locations (1)

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

Tianjin, China

Key Dates

Start Date

August 10, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

August 11, 2025

Enrollment

ESTIMATED participants

Conditions

POEMS Syndrome

Interventions

CM336 (BCMA/CD3 bispecific antibody)

DRUG

Contacts

Gang An, MD

CONTACT

13502181109 angang@ihcams.ac.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BCMA/CD3 BsAb Therapy for POEMS Syndrome

Inclusion Criteria

Exclusion Criteria

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