BCMA/CD3 BsAb Therapy for POEMS Syndrome

NCT ID: NCT07115654

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-10
• Study Completion Date: 2027-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BsAbs-treatment group

Group Type: EXPERIMENTAL

CM336 (BCMA/CD3 bispecific antibody)

Intervention Type: DRUG

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

Interventions

CM336 (BCMA/CD3 bispecific antibody)

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Tianjin, , China

Countries

China

Central Contacts

Gang An, MD

Role: CONTACT

angang@ihcams.ac.cn

13502181109

Other Identifiers

IIT2025047

Identifier Type: -

Identifier Source: org_study_id