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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BsAbs-treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM336 (BCMA/CD3 bispecific antibody) | Drug | CM336 is a bispecific antibody targeting BCMA and CD3, designed to redirect T cells to eliminate abnormal plasma cells. |
|
| 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
Not meeting the diagnostic criteria for POEMS syndrome, including:
History of prior anti-plasma cell therapy, such as melphalan, cyclophosphamide, proteasome inhibitors, IMiDs, monoclonal antibodies, CAR-T, or bispecific antibodies (except:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang An, MD | Contact | 13502181109 | angang@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Tianjin | 300020 | China |
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| ID | Term |
|---|---|
| D016878 | POEMS Syndrome |
| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |