BCMA/CD3 BsAb Therapy for POEMS Syndrome

A Prospective Single-Arm Clinical Trial of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: POEMS Syndrome
• Intervention / Treatment: Drug: CM336 (BCMA/CD3 bispecific antibody)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gang An, MD; Phone Number: 13502181109; Email: angang@ihcams.ac.cn

Study Locations

• China
  • Tianjin, China, 300020
    • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BsAbs-treatment group	Drug: CM336 (BCMA/CD3 bispecific antibody); CM336 is a bispecific antibody targeting BCMA and CD3, designed to redirect T cells to eliminate abnormal plasma cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 4, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Bispecific antibody; POEMS syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Disease; Hematologic Diseases; Immunoproliferative Disorders; Congenital Abnormalities; Abnormalities, Multiple; Paraproteinemias; Blood Protein Disorders; Polyneuropathies; Syndrome; POEMS Syndrome; Immunologic Factors; Physiological Effects of Drugs; Antibodies; Antibodies, Bispecific
• Other Study ID Numbers: IIT2025047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No