NCT05223699终止1 期
A Phase I/II, Dose-Escalation Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 16
- 主要终点
- Incidence rate of treatment emergent adverse events (TEAEs) leading to study drug discontinuation
研究概览
简要总结
This research study is designed to selectively deplete CD117-positive cells from participants with AML and MDS-EB.
详细描述
This is a multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential anti-leukemia activity and to establish the minimum safe and biologically-effective dose of a single dose of MGTA-117 in relapsed/refractory (R/R) CD117+ AML participants and participants with MDS-EB. The study consists of escalating single-dose cohorts using a standard 3+3 design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Participant must have a World Health Organization (WHO)-defined diagnosis of R/R AML and meet one of the following criteria:
- •The participant has experienced primary AML induction failure or R/R AML
- •The participant has a WHO-defined diagnosis of MDS-EB and has failed/is refractory to HMA
- •Presence of MRD in morphologic CR
- •CD117+ based on IHC or flow cytometry
- •Participant must have an identified HSC donor (related donor or unrelated donor), haplo-identical transplant donor, or umbilical blood donor.
- •Participant's Eastern Cooperative Oncology Group (ECOG) performance status must be ≤
- •Participant must have adequate baseline hepatic function. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤2 x upper limit of normal (ULN), and serum bilirubin ≤1.5 x ULN.
- •Estimated creatinine clearance ≥60 mL/min
- •Adequate cardiac function as demonstrated by cardiac left ventricular ejection fraction ≥40% or perform New York Heart Association (NYHA) classification I and II
排除标准
- •Acute promyelocytic leukemia (APL).
- •Known active central nervous system (CNS) leukemia or chloroma (granulocyte sarcoma).
- •Received HSCT within 6 months prior to dosing
- •Received chimeric antigen-receptor cell therapies within 6 months prior to dosing
- •Has active graft-versus-host disease (GVHD).
- •Active hepatitis B (Hep-B) or hepatitis C (Hep-C) infection or history of human immunodeficiency virus (HIV).
- •Participant with a QTc value >470 msec
- •Participant has received another investigational drug or device within 14 days or 5 half-lives of dosing, whichever is longer.
- •Participant has any clinically significant medical condition, which in the opinion of the Investigator may place the participant at an unacceptable risk.
- •Active uncontrolled systemic bacterial, fungal, or viral infection
- •Participant has a history of serious allergic reactions, which in the opinion of the Investigator may pose an increased risk of serious infusion reactions.
- •Participant has had any systemic antileukemia treatment within 14 days except hydroxyurea, which is permitted until 24 hours prior to MGTA-117 dosing.
- •Participant has received prior anti-CD117 antibody treatment.
- •Participant has received gemtuzumab ozogamicin (Mylotarg) within the last 3 months prior to dosing.
- •Participant has received recent monoclonal antibody as anti-leukemic therapy within the last 30 days or 5 half-lives, whichever is longer.
- •Participant has received recent vaccination within the last 14 days prior to dosing.
- •Participant has Grade 2 or higher electrolyte abnormality at screening
结局指标
主要结局
Incidence rate of treatment emergent adverse events (TEAEs) leading to study drug discontinuation
时间窗: 21 days
To establish a minimum safe and biologically effective dose
时间窗: 21 days
The incidence of qualifying protocol-defined dose-limiting toxicities
Incidence rate of treatment emergent >= Grade 3 clinical laboratory abnormalities as assessed by CTCAE v5.0
时间窗: 21 days
Assess the clinically significant changes from baseline in vital signs, ECGs and laboratory parameters
时间窗: 21 days
Pharmacokinetics profile of MGTA-117
时间窗: 21 days
Investigate area under the curve (AUC)
次要结局
未报告次要终点
研究者
研究点 (16)
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