Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2025-08-10
Last updated
2025-08-11
Condition(s) studied
POEMS Syndrome
Investigational drug(s) / intervention(s)
CM336 (BCMA/CD3 bispecific antibody)
CM336 (BCMA/CD3 bispecific antibody): CM336 is a bispecific antibody targeting BCMA and CD3, designed to redirect T cells to eliminate abnormal plasma cells.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
78 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin
China
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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