NCT06119256招募中1 期
Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年8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
- Adverse events
研究概览
简要总结
This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV virus infection after allogenic HSCT.
详细描述
EB virus (EBV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A*02:01/11:01/24:02-restricted EBV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate EBV-TCR-T cells. An escalated dose ranging from 3×10^5/kg to 1×10^6/kg of EBV-TCR-T cells will be infused into patients with EBV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic EBV-TCR-T cell therapy will be evaluated.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-75 years, gender unlimited.
- •Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with EBV infection after allo-HSCT.
- •Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age<16y).
- •TCR-T cell donor inclusion criteria: 1) Age 8-70 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8~4) × 10^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.
排除标准
- •Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.
- •Patients with severe kidney disease (Cr > 3×normal value), liver damage (TBIL >2.5×upper limit of normal value, ALT and AST > 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion.
- •Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
- •Have other malignancies.
- •Have relapsed and uncontrolled hematologic malignancies.
- •Serologically positive for HIV-Ab or TAP-ab.
- •Pregnant or lactating women.
- •Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.
- •Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
结局指标
主要结局
Adverse events
时间窗: 1 year after EBV-TCR-T treatment
Percentage of participants with adverse events.
次要结局
- The time to EBV-DNA negative(180 days after EBV-TCR-T treatment)
- The overall response rate to EBV-TCR-T treatment(28,90,180,365,730 days after EBV-TCR-T treatment)
- The incidence of EBV reactivation after EBV-TCR-T treatment(1 year after EBV-TCR-T treatment)
- Maximum Plasma Concentration (Cmax) of EBV-TCR-T cells(28 days after EBV-TCR-T treatment)
- Area under the plasma concentration versus time curve (AUC) of EBV-TCR-T cells(28 days after EBV-TCR-T treatment)
- Half life time (T1/2) of EBV-TCR-T cells(28 days after EBV-TCR-T treatment)
- Concentration levels of cytokines(28 days after EBV-TCR-T treatment)
- Maximum tolerated dose(28 days after EBV-TCR-T treatment)
- The proportion of EBV-DNA negative patients(180 days after EBV-TCR-T treatment)
- Changes of EBV-DNA copies number(1 year after EBV-TCR-T treatment)
- Dose-limiting toxicity(28 days after EBV-TCR-T treatment)
- The incidence of EBV-PTLD(1 year after EBV-TCR-T treatment)
- Persistence of EBV-TCR-T cells(1 year after EBV-TCR-T treatment)
- The duration of response(1 year after EBV-TCR-T treatment)
- The complete response rate to EBV-TCR-T treatment(28,90,180,365, and 730 days after EBV-TCR-T treatment)
- Concentration levels of CRP(28 days after EBV-TCR-T treatment)
- The time to response(180 days after EBV-TCR-T treatment)
- Concentration levels of ferritin(28 days after EBV-TCR-T treatment)
研究者
Daihong Liu
Director
Chinese PLA General Hospital
研究点 (1)
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