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NCT Number: NCT07115654

BCMA/CD3 BsAb Therapy for POEMS Syndrome

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.

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Key information

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Tianjin, 300020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Chronic inflammatory demyelinating polyneuropathy (CIDP),
  • MGUS, multiple myeloma, amyloidosis, or other plasma cell disorders not meeting POEMS diagnostic criteria.
  • 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.

Treatment and study plan

CM336 (BCMA/CD3 bispecific antibody)

Drug

CM336 is a bispecific antibody targeting BCMA and CD3, designed to redirect T cells to eliminate abnormal plasma cells.

Primary outcomes

  1. Incidence of Adverse Events and Overall Response Rate (ORR)

    Time frame: Up to 12 months after treatment initiation

    To evaluate the safety and efficacy of BCMA/CD3 bispecific antibody therapy in patients with POEMS syndrome.

Secondary outcomes

  1. Hematologic Response Rate

    Time frame: From treatment initiation to 3 months after end of treatment

  2. VEGF Response Rate

    Time frame: From treatment initiation to 3 months after end of treatment

  3. Duration of Response (DOR)

    Time frame: From first documented response to 6 months after end of treatment

  4. Disease Control Rate (DCR)

    Time frame: From treatment initiation to 3 months after end of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Gang An, MD

CONTACT

[email protected]

13502181109

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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