Safety and Efficacy of Universal Off-the-shelf CAR-NK Cells Targeted CD123 (JD123 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1-month DLTs
研究概览
简要总结
This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).
详细描述
This is a dose-escalation study of CD123-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) derived from a healthy donor. The relapsed/refractory AML patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by infusion of JD123 injections. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.
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
- 未提供
排除标准
- •Active Central nervous system leukemia;
- •Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
- •Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids);
- •Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
- •History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
- •Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;
- •Women who are pregnant (urine/blood pregnancy test positive) or lactating;
- •Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;
- •Known alcohol dependence or drug dependence;
- •According to the investigator's judgment, the patient has other unsuitable grouping conditions.
研究组 & 干预措施
Experimental: Experimental: JD123 injection.
The relapsed/refractory AML patients will receive JD123 injections up to 3 dose levels (5.0×108 cells/dose，1.5×109 cells/dose，3.0×109 cells/dose) after FC chemotherapy.
干预措施: JD123 injection (Drug)
结局指标
主要结局
1-month DLTs
时间窗: 1-month
Dose limiting toxicities (DLTs)
次要结局
- 1-year PFS(1-year)
- 3-month Peak(3-month)
- 3-month CR/CRi(3-month)
- 1-year OS(1-year)
- 1-year MRD(-)(1-year)
- 3-month AUC(3-month)
研究者
Xiao-Jun Huang
Professor
Peking University People's Hospital