NCT05148442终止1 期
A Phase Ia/Ib Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of treatment related AEs
研究概览
简要总结
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients.
详细描述
Phase 1a/1b study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in patients with myeloid tumor. Phase 1a is the dose escalation part of the study and Phase 1b is the dose expansion part. Combination therapy with HMA(Azacitidine or Decitabine) will be evaluated.
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
- •Patients who met the diagnostic criteria of recurrent / refractory AML (WHO 2016)(primordial cells in bone marrow ≥ 5%) (excluding APL and bcr-abl positive AML ) and underwent treatment.
- •Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.
- •Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)
- •Male or female subject above 18 years old
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 ~
- •Must have adequate organ function
排除标准
- •Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN
- •Transformation or treatment related AML/MDS.
- •PV/MF/AML/MDS evolved from Essential thrombocythemia
- •Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year
- •Central nervous system leukemia infiltration
- •Previous history of chronic hemolytic anemia or screening Coombe test positive
- •Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- •Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
- •Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose
- •Uncontrolled concurrent diseases
- •Subjects who are allergic to the ingredients of the study drug
- •Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment
研究组 & 干预措施
IBI322
Experimental
干预措施: IBI322 (Drug)
结局指标
主要结局
Number of treatment related AEs
时间窗: Up to 90 days post last dose
safety and tolerability
次要结局
- Number of patients with response(Last patient enrolled+24 weeks)
研究者
研究点 (1)
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