NCT07115654 BCMA/CD3 BsAb Therapy for POEMS Syndrome
| NCT ID | NCT07115654 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | POEMS Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2025-08-04 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07115654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 78 Years, studying POEMS Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07115654 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07115654 currently recruiting?
Yes, NCT07115654 is actively recruiting participants. Contact the research team at angang@ihcams.ac.cn for enrollment information.
Where is the NCT07115654 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07115654 clinical trial?
NCT07115654 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 10 participants.