BCMA/CD3 bispecific antibody therapy for POEMS syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, investigator-initiated Phase 2 trial evaluating CM336 in patients with POEMS syndrome. Participants will receive the BCMA/CD3 bispecific antibody to determine safety and preliminary efficacy. Eligibility includes adults with POEMS diagnosed by the 2025 Chinese Expert Consensus and adequate organ function, while excluding those with other plasma cell disorders or prior anti-plasma cell therapies. The study is conducted at the Institute of Hematology & Blood Diseases Hospital in Tianjin, China. Outcomes will inform whether CM336 could be a viable treatment option for POEMS syndrome.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Gang An, MD
• Email: angang@ihcams.ac.cn
• Phone: 13502181109

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using CT103A cells to treat autoimmune diseases of the nervous system

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.