POEMS Syndrome
Conditions
Keywords
POEMS syndrome, Bispecific antibody
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.
Interventions
CM336 is a bispecific antibody targeting BCMA and CD3, designed to redirect T cells to eliminate abnormal plasma cells.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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 |
Countries
China
Contacts
Primary ContactGang An, MD
Outcome results
None listed