NCT05463640尚未招募1 期
To Evaluate the Safety and Efficacy of ADGRE2 CAR-T in Patients With Relapsed and Refractory Acute Myeloid Leukemia
Zhejiang University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in cytokine level after ADGRE2 CAR-T infusion.
研究概览
简要总结
This is an open label, phase I study to assess the safety and efficacy of ADGRE2 CAR-T in patients with relapsed and refractory acute myeloid leukemia
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
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
- •Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
- •The expression of ADGRE2 in AML blast is positive ;
- •The patient has recovered from the toxicity of previous treatment;
- •ECOG score ≤ 2 and expected survival period is not less than 3 months;
- •Adequate organ function defined as:
- •AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
- •Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
- •From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception
排除标准
- •Diagnosis of acute promyelocytic leukemia;
- •History or presence of a CNS disorder;
- •HBsAg or HBcAb are positive; HCV 、HIV and Syphilis antibody are positive, CMV DNA in peripheral blood is more than≥500 copies /mL;
- •History of severe hypersensitivity reaction;
- •History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
- •History of organ transplant surgery;
- •Required systemic application of immunosuppressive or other drugs;
- •Auto-SCT within the 3 months before enrollment;
- •Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));
- •Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;
- •Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;
- •Live vaccine received within the ≤ 4 weeks before enrollment;
- •Persons with serious mental illness;
- •History of major surgical operations four weeks before enrollment;
- •History of alcoholism or substance abuse;
- •Was identified by the investigators as unsuitable to participate in the study
结局指标
主要结局
Changes in cytokine level after ADGRE2 CAR-T infusion.
时间窗: Up to 2 years after ADGRE2 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion. Cytokines include IL-2、IL-6、TNF-α、IFN-γ.
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion.
时间窗: Up to 2 years after ADGRE2 CAR-T infusion
Track CAR-T cells expansion in patients after infusion by flow cytometry and qPCR.
次要结局
- Overall response Rate(ORR)(Up to 2 years after ADGRE2 CAR-T infusion)
- Complete response rate(CRR)(Up to 2 years after ADGRE2 CAR-T infusion)
- Partial response Rate (PRR)(Up to 2 years after ADGRE2 CAR-T infusion)
研究者
He Huang
Professor
Zhejiang University
研究点 (1)
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