NCT07409454招募中2 期
A Prospective, Single-Arm Clinical Trial of MRD-Guided BCMA/CD3 Bispecific Antibody as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年7月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Minimal residual disease (MRD) negativity conversion rate
研究概览
简要总结
This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of the BCMA/CD3 bispecific antibody (CM336) as maintenance therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to understand and voluntarily signs the informed consent form (ICF).
- •Age ≥ 18 years.
- •Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
- •MRD positivity (≥10-⁵) detected by EuroFlow.
- •Previous therapy limited to first-line treatment only, including: (1) Induction therapy with a 3- or 4-drug regimen containing a proteasome inhibitor and/or an immunomodulatory drug and/or an anti-CD38 monoclonal antibody; (2) Single or tandem autologous stem cell transplantation (ASCT); (3) Up to 2-4 cycles of consolidation therapy post-ASCT are permitted, with the total number of induction plus consolidation cycles not exceeding
- •Completion of ASCT within ≤12 months from the start of induction therapy; and ≤6 months from the most recent ASCT at enrollment (≤7 months if consolidation therapy was administered).
- •No prior maintenance therapy.
- •Achieved at least a partial response (≥PR) according to the IMWG 2016 response criteria.
- •Presence of measurable disease at diagnosis.
排除标准
- •Prior treatment with genetically modified adoptive cellular therapy.
- •History of allogeneic stem cell transplantation or solid organ transplantation.
- •Disease progression prior to enrollment (per IMWG 2016 response criteria), or presence of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or light-chain amyloidosis not attributable to symptomatic multiple myeloma.
- •Central nervous system involvement.
研究组 & 干预措施
BsAbs-treatment group
Experimental
干预措施: anti-BCMA/CD3 bispecific antibody (Drug)
结局指标
主要结局
Minimal residual disease (MRD) negativity conversion rate
时间窗: Up to 24 months
次要结局
- Duration of MRD negativity(Up to 24 months)
- Progression-Free Survival(From enrollment to the date of disease progression or death, up to approximately 24 months.)
- Overall Survival (OS)(From start of treatment until death from any caus, up to approximately 24 months.)
- Incidence and severity of adverse events (AEs)(From the first dose through 30 days after the last dose, up to approximately 24 months.)
研究者
研究点 (1)
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