NCT05106907招募中1 期
An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD19(ThisCART19) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Treatment related adverse events
研究概览
简要总结
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
详细描述
ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
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
- •Age 18-70 years old, no gender and race limited;
- •Estimated life expectancy > 12 weeks deemed by investigator；
- •CD19 were positive by histopathology and/or cytology diagnosis；
- •Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
- •Relevant indicators for disease or assessment within 4 weeks after the last treatment;
- •Quality of Life Score (KPS) >50%；
- •Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST <3 upper limit of normal (ULN); bilirubin<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
- •No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
- •Unsuitable conditions for stem cell transplantation;
- •Signed informed consent form (ICF).
排除标准
- •Women in pregnancy or lactation;
- •In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
- •The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L;
- •Abnormal vital signs and failure to cooperate with examination;
- •Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
- •Highly allergic constitution or history of severe allergy;
- •Patients with systemic infection or severe local infection requiring anti-infection treatment;
- •Patients with severe autoimmune diseases;
- •Presence of any other conditions that are unsuitable for this study as judged by the investigator.
结局指标
主要结局
Treatment related adverse events
时间窗: 90 days post infusion
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
次要结局
- Overall survival time(3 years)
- Progression free survival time(3 years)
- Overall Remission Rate (ORR)(up to 90 days)
- Event-free survival (EFS)(3 years)
研究者
研究点 (1)
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