Not yet recruiting NCT07115654
BCMA/CD3 BsAb Therapy for POEMS Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CM336 (BCMA/CD3 bispecific antibody).
- Who it may be relevant to
- Registry conditions: POEMS Syndrome. Basic parameters: 18 years — 78 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Single-Arm Clinical Trial of BCMA/CD3 BsAb Therapy for POEMS Syndrome
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence of Adverse Events and Overall Response Rate (ORR) [Time frame: Up to 12 months after treatment initiation]
Secondary outcome measures (4)
- Hematologic Response Rate [Time frame: From treatment initiation to 3 months after end of treatment]
- VEGF Response Rate [Time frame: From treatment initiation to 3 months after end of treatment]
- Duration of Response (DOR) [Time frame: From first documented response to 6 months after end of treatment]
- Disease Control Rate (DCR) [Time frame: From treatment initiation to 3 months after end of treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07115654 · IIT2025047