A Study to Evaluate Pharmcokinetics, Pharmacodynamics , Efficacy and Safety of 6MW3211 Monotherapy and in Combination With Azacitidine(AZA) or AZA Plus Venetoclax(VEN) in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- CCR
研究概览
简要总结
This study is aimed to evaluate the efficacy, safety, immunogenicity and pharmkinetics, pharmacodynamics of 6MW3211 as monotherapy and in combination with AZA or AZA plus VEN in patients with AML/MDS.
详细描述
This study is a phase I/II study to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of 6MW3211 monotherapy or combined with AZA or AZA plus VEN in patients with AML and MDS. There will be 2 parts of this study. The phase Ib is about monotherapy of 6MW3211 and Phase II is designed to evaluate the safety and efficacy of 6MW3211 combined with AZA or AZA plus VEN in patients with relapse/refractory and newly diagnosed AML and MDS.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the study and sign the informed consent;
- •18≤age≤75，Men or women；
- •AML patients (except acute promyelocytic leukemia) : subjects who meet the diagnostic criteria for relapsed/refractory AML according to the diagnostic criteria of 2021 Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory AML ； MDS patients: MDS patients were diagnosed as having moderate risk of recurrence/refractory (IPSS-R score >3.5) according to WHO diagnostic criteria in 2016
- •ECOG:0-2;
- •Survival expectation of at least 3 months;
- •Adequate organs and hematopoietic functions; only applicable for phase II :
- •Newly diagnosed AML with intolerance to standard induction chemotherapy who should meet one of following criterias: age ≥75 years; ECOG 2-3; chronic heart failure requiring treatment or EF≤50% or chronic stable angina pectoris; DLCO≤65% or FEV1≤65%;30ml/min≤CrCl<45ml/min；1.5 x ULN<total bilirubin≤3.0 x ULN
- •Newly diagnosed intermediate- and high-risk (International Prognostic Scoring System IPSS-R) MDS
- •Exclusion criteria:
- •Myeloid proliferative diseases (MPN), including primary myelofibrosis (PMF), polycythemia vera (PV), chronic myelogenous leukemia (CML), and primary thrombocytopenia (ET); Or have myelodysplastic myeloid proliferative tumors (MDS-MPN), including chronic monocytic leukemia (CMML), atypical chronic myelogenous leukemia (aCML), juvenile granulomatous single-cell leukemia (JMML), and acute promyelocytic leukemia (M3);
- •Recurrence after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year;
- •Known infiltration of central nervous system leukemia；
- •Active or uncontrolled autoimmune diseases；
- •Has a history of other malignancies；
- •Has known inherited or acquired hemorrhagic disorders；
- •Pregnant or lactating women；
排除标准
- 未提供
研究组 & 干预措施
6MW3211
Phase I, 6MW3811 monotherapy in 2 dose levels of 30mg/kg or 45mg/kg; phase II, 6MW3811 will be given in combination with AZA( cohort1) and AZA plus VEN(cohort 2)
干预措施: 6MW3211 injection with Intravenous Infusion (Drug)
结局指标
主要结局
CCR
时间窗: 1 year
Compound complete response rate
ORR
时间窗: 1 year
Objective Response Rate
phase II: safety
时间窗: Up to 28 days post last dose
to evaluate the percentage of participants with adverse events and serious adverse events of 6MW3211 combination therapy in AML and MDS
次要结局
- Tmax(1 year)
- RFS(1 year)
- AE(Up to 28 days post last dose)
- PK Parameter(1 year)
- EFS(1 year)
- OS(1 year)
- DoCR(1 year)
- Cmax(1 year)
- T1/2(1 year)