NCT05645601招募中1 期
Early Clinical Study of Allogenic CAR-NK Targeted CD19 (JD010) in the Treatment of Adult Relapsed or Refractory B-cell Malignancies
Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of JD010 in adult patients with relapsed or refractory B cell hematologic malignancies. JD010 injection is a CD19-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) derived from a healthy donor
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
- •Age ≥ 18 years old, no gender or race;
- •Expected survival period ≥ 3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- •Confirmed relapsed/refractory B-cell malignancies and tumor cells expressing CD19;
- •Adequate organ function:
- •A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;
- •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
- •Central nervous system involved;
- •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.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 3 months
Dose limiting toxicities (DLTs)
时间窗: 1 Months
Treatment-related adverse events
时间窗: 3 months
次要结局
- Overall Survival (OS)(12 months)
- Proportion of subjects with minimal-residual disease (MRD) negative response(12 months)
- Progression free survival (PFS)(12 months)
研究者
研究点 (1)
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