NCT05970822招募中1 期
A Phase 1b Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of BC3402 in Combination With Azacitidine in Subjects With Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of patients with AEs and SAEs Primary endpoint:Incidence of dose limiting toxiecities(DLTs) and incidence of DLT events within 28 days (first cycle)
研究概览
简要总结
The study is to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of BC3402 in combination with azacitidine (AZA) in subjects with Myelodysplastic Syndrome (MDS) and Chronic myelomonocytic leukemia (CMML)
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
- •MDS and CMML subjects with higher risk;
- •Age ≥ 18 years old;
- •Eastern Cooperative Oncology Group score of 0~2;
- •Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT);
- •Subjects should take effective contraceptive measures
- •Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
排除标准
- •Prior exposure to anti-TIM-3 therapy at any time
- •Previous HSCT
- •Live vaccine administered within 4 weeks prior to start of treatment
- •Current use or use within 7 days prior to start of treatment of systemic steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed.
- •Other protocol-defined Inclusion/Exclusion may apply.
研究组 & 干预措施
BC3402+azacitidine
Experimental
Subjects will receive azacitidine and BC3402 in a treatment cycle.
干预措施: BC3402 (Drug)
BC3402+azacitidine
Experimental
Subjects will receive azacitidine and BC3402 in a treatment cycle.
干预措施: Azacitidine (Drug)
结局指标
主要结局
Number of patients with AEs and SAEs Primary endpoint:Incidence of dose limiting toxiecities(DLTs) and incidence of DLT events within 28 days (first cycle)
时间窗: 2.5 years
To evaluate the safety and tolerability of BC3402
次要结局
未报告次要终点
研究者
研究点 (1)
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