BCMA/CD3 BsAb Therapy for POEMS Syndrome

NCT07115654 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2025047
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

POEMS Syndrome

Keywords

POEMS syndrome; Bispecific antibody

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events and Overall Response Rate (ORR)

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

  Up to 12 months after treatment initiation

Secondary Outcomes (4)

• Hematologic Response Rate

  From treatment initiation to 3 months after end of treatment

• VEGF Response Rate

  From treatment initiation to 3 months after end of treatment

• Duration of Response (DOR)

  From first documented response to 6 months after end of treatment

• Disease Control Rate (DCR)

  From treatment initiation to 3 months after end of treatment

Study Arms (1)

BsAbs-treatment group

EXPERIMENTAL

Drug: CM336 (BCMA/CD3 bispecific antibody)

Interventions

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.

BsAbs-treatment group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

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

Tianjin, 300020, China

Location

MeSH Terms

Conditions

POEMS Syndrome

Condition Hierarchy (Ancestors)

Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Gang An, MD

CONTACT

13502181109; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)