NCT07115654尚未招募2 期
A Prospective Single-Arm Clinical Trial of BCMA/CD3 BsAb Therapy for POEMS Syndrome
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年8月10日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events and Overall Response Rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosed with POEMS syndrome according to the 2025 Chinese Expert Consensus.
- •Deemed suitable for BCMA/CD3 bispecific antibody therapy by the investigator.
- •ECOG performance status 0-
- •Adequate organ function.
- •Provided written informed consent.
排除标准
- •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.
- •History of prior anti-plasma cell therapy, such as melphalan, cyclophosphamide, proteasome inhibitors, IMiDs, monoclonal antibodies, CAR-T, or bispecific antibodies (except:
- •Immunosuppressants used for autoimmune neuropathy;
- •Bisphosphonates used for bone disease;
- •Topical or low-dose steroids ≤20 mg/day for rheumatic disease).
- •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.
研究组 & 干预措施
BsAbs-treatment group
Experimental
干预措施: CM336 (BCMA/CD3 bispecific antibody) (Drug)
结局指标
主要结局
Incidence of Adverse Events and Overall Response Rate (ORR)
时间窗: Up to 12 months after treatment initiation
To evaluate the safety and efficacy of BCMA/CD3 bispecific antibody therapy in patients with POEMS syndrome.
次要结局
- 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)
研究者
研究点 (1)
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