Clinical Trials in China / NCT07115654
Recruiting
Phase 2
BCMA/CD3 BsAb Therapy for POEMS Syndrome
NCT07115654 · tracked via the Priya Life Science China tracker
Condition(s) studied
POEMS Syndrome
Investigational drug(s) / intervention(s)
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
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 | Recruiting |
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Official registry record
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.
View NCT07115654 on ClinicalTrials.gov ↗ ← All trials in China