NCT04014881Unknown1 期
Single-center, Open-label, Single-arm Clinical Study of Efficacy and Safety of Anti-CD123 CAR-T Therapy in Patients With Refractory/Relapsed CD123+ Acute Myeloid Leukemia.
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年7月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-related Adverse Events
研究概览
简要总结
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD123 CAR-T cells in patients with refractory/relapsed CD123+ Acute Myeloid Leukemia.
详细描述
CD123 is a transmembrane subunit of the IL-3 receptor expressed on AML blasts. The investigators have conducted a third generationCD123-targeted CAR containing CD137 and CD28 costimulatory domains.This study aims to evaluate the safety and efficacy of anti-CD123 CAR-T cells in patients with relapsed/refractory CD123+ 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological and histological examination confirmed CD123+ refractory or relapsed Acute Myeloid Leukemia.
- •A. Diagnostic criteria for recurrent AML: After complete remission (CR), leukemia cells or bone marrow primordial cells > 0.050 (except for bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration appears again in peripheral blood.
- •B．Diagnostic criteria for refractory AML(Meeting one of the following)
- •i. ineffectiveness after the first standard regimen treatment of 2 courses.
- •ii. patients relapse within 12 months after consolidation and intensive treatment after CR.
- •iii. Patients relapse 12 months later and fail to respond to conventional chemotherapy.
- •iv. Patients with two or more recurrences.
- •v. Patients with persistent extramedullary leukemia.
- •vi. Patients with recurrence after CR and unsuitable for HSCT (auto/allo-HSCT).
- •Aged 18 to 70 years (including 18 and 70 years old).
- •At least one measurable or evaluable lesion：AML patients with positive or relapsed positive bone marrow MRD.
- •ECOG≤ 2 and expected lifetime ≥3 months.
- •Adequate organ function:
- •A. Liver function: ALT/AST≤3 ULN. Total bilirubin≤2 ULN.
- •B. Renal function: eGFR> 60 mL/min/1.73 m2, or creatinine clearance ≥45mL/min.
- •C. Lung function: Carbon Monoxide (DLCO) or Forced Expiratory Volume in the first second (FEV1) > 45% predicted.
- •D. Cardiac function: LVEF ≥ 50%.
- •The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to < 1 level at admission (except for low toxicity such as alopecia).
- •Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.
- •Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
排除标准
- •Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- •Male or female with a conception plan in the past 1 years.
- •Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
- •Uncontrolled infectious disease within 4 weeks prior to enrollment.
- •Active hepatitis B/C virus.
- •HIV infected patients.
- •Suffering from a serious autoimmune disease or immunodeficiency disease.
- •The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
- •The patient participated in other clinical trials within 6 weeks prior to enrollment.
- •Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
- •Suffering from mental illness.
- •Patient has drug abuse/addiction.
- •Central nervous system involvement.
- •According to the investigator's judgment, the patient has other unsuitable grouping conditions.
研究组 & 干预措施
CD123+ Acute Myeloid Leukemia
Experimental
Patients will receive CD123-targeted CAR-T cells in the dose-climbing trial. Each dose group has 3 patients and the the maximum dose can be extended.
干预措施: Third-generation anti-CD123 CAR-T cells (Biological)
结局指标
主要结局
Incidence of Treatment-related Adverse Events
时间窗: 3 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).
次要结局
- Overall remission rate(ORR) of anti-CD123 CAR-T Therapy in patients with refractory/relapsed CD123+ Acute Myeloid Leukemia(3 years)
- Overall survival(OS) of anti-CD123 CAR-T cells in patients with refractory/relapsed CD123+ Acute Myeloid Leukemia(3 years)
- Duration of Response(DOR) of anti-CD123 CAR-T cells in patients with refractory/relapsed CD123+ Acute Myeloid Leukemia(3 years)
- Progress-free survival(PFS) of anti-CD123 CAR-T cells in patients with refractory/relapsed CD123+ Acute Myeloid Leukemia(3 years)
- Rate of anti-CD123 CAR-T cells in bone marrow cells and peripheral blood cells(3 years)
- Quantity of anti-CD123 CAR copies in bone marrow cells and peripheral blood cells(3 years)
研究者
MEI HENG
Principal Investigator
Wuhan Union Hospital, China
研究点 (1)
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