A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD5CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Patients who met all the inclusion criteria were eligible for enrolment):
- •Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., HSCT or chemotherapy);
- •Male or female, age 14-70;
- •Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2;
- •life expectancy is at least 60 days;
- •Subjects should be capable of understanding and signing the informed consent form prior to any screening procedures. Subjects are willing to follow the study visit schedule and associated study procedures as specified in the protocol. Candidates between the ages of 19-70 years old will need to be sufficiently aware of and capable of signing the informed consent form; underage candidates between the ages of 14-18 years old will need to be sufficiently aware of the informed consent form and their legal guardian will also need to sign the informed consent form separately.
排除标准
- •(Patients who fulfil any of the following criteria may not be enrolled):
- •Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load >30%; patients without history of allogeneic HSCT and peripheral blood tumour load >30%;
- •Intracranial hypertension or cerebral impaired consciousness;
- •Symptomatic heart failure or severe arrhythmia;
- •Symptoms of severe respiratory failure;
- •With other types of malignancy;
- •Diffuse intravascular coagulation;
- •Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
- •With sepsis or other uncontrollable infection;
- •Suffering from uncontrollable diabetes mellitus;
- •Severe mental disorders;
- •Have significant intracranial lesions on cranial MRI;
- •Organ transplantation (excluding haematopoietic stem cell transplantation) history;
- •Female patients (patients of childbearing potential) with positive blood HCG test;
- •Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.
研究组 & 干预措施
CD5 CAR-T therapy
Enrolled patients were treated with anti-CD5 CAR-T cells, with or without allo-HSCT bridging.
干预措施: CD5 CAR-T cells infusion (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: 21 days
Total number, incidence and severity of adverse events (AEs) within 21 days of CD5 CAR-T infusion.
Dose-limiting toxicity (DLT)
时间窗: 21 days
Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD5CAR-T infusion.
次要结局
- Duration of response (DOR)(up to 2 years)
- Objective Response Rate (ORR)(21, 90 days)
研究者
Jing Pan
Director of Dept of Hemato-Oncology and Immunotherapy
Beijing GoBroad Hospital