BCMA/CD3 BsAb Therapy for POEMS Syndrome

Not Applicable

Not yet recruiting

• Conditions: POEMS Syndrome
• Interventions: Drug: CM336 (BCMA/CD3 bispecific antibody)

• Registration Number: NCT07115654
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study Start: 2025-08-10
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BsAbs-treatment group	CM336 (BCMA/CD3 bispecific antibody)	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events and Overall Response Rate (ORR)	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China