NCT04684472招募中1 期
Phase I, Open Label, Study of CXCR4 Modified CD19 CAR-T Therapy in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
Liqun Zou1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年3月17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
- 18
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma (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
- •Male or female aged 18-70 years;
- •Estimated survival time ≥ 12 weeks;
- •Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):
- •Ineffectively or relapses after 2 or more remedial treatments
- •Relapse after auto-HSCT or unsuitable for auto-HSCT;
- •At least one assessable tumor lesion;
- •ECOG performance status 0 to 2;
- •Creatinine clearance rate≥ 60 ml/min, ALT and AST ≤ 2.5 times of upper limit of normal, total bilirubin ≤ 1.5 times of upper limit of normal;
- •Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study;
- •Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
排除标准
- •Patients with other uncontrolled malignancies;
- •Previously treated with any CAR-T cell product or other genetically-modified T cell therapy;
- •Patients with HIV infection, hepatitis B (HBsAg positive) or hepatitis C（anti-HCV positive);
- •Patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis;
- •Patients with atrial or ventricular involvement by B-cell malignancies;
- •Patients with tumor mass require urgent treatment, such as ileus or vascular compression;
- •Patients with severe disease or other uncontrolled diseases that were not suitable for this trial, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, grade 2-3 hypertension;
- •Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events occurred within 30 days prior to randomization. If patients receive anticoagulant therapy, the treatment dose must be stable prior to randomization;
- •Any situations that the investigators believes were not suitable for this trial;
- •Long-term use of immunosuppressive agents after organ transplantation, except for the patients recently or currently receiving inhaled steroids;
- •Pregnant(or lactation) women;
- •Patients with severe active infections(excluding simple urinary tract infection and bacterial pharyngitis)within 30 days prior to randomization
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after modified CD19 CAR-T cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events [Safety and Tolerability]
时间窗: Up to 5 years after modified CD19 CAR-T cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- B-cell malignancies, disease control rate (DCR)(Month 6,12,18 and 24)
- B-cell malignancies, progression-free survival（PFS）(Up to 2 years after modified CD19 CAR-T cells infusion)
- B-cell malignancies, Overall survival(Up to 2 years after modified CD19 CAR-T cells infusion)
- B-cell malignancies, Overall response rate(ORR)(3 months, 6 months)
研究者
Liqun Zou
Professor of Department of Medical Oncology
Sichuan University
研究点 (1)
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