NCT04599556招募中1 期
Clinical Trial for the Safety and Efficacy of Anti-CD7 Chimeric Antigen Receptor Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy
Zhejiang University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2021年4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
- 81
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L;
- •Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- •There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- •The estimated survival time is more than 3 months;
- •ECOG score was 0-2;
- •The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
- •For T-ALL/LBL:
- •Patients is histologically diagnosed with CD7 Positive T-ALL/LBL according to the Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (ALL) (
- •V1) by National Comprehensive Cancer Network (NCCN).
- •The diagnosis is consistent with r/r CD7 + T-ALL/LBL, and includes any of the following conditions:
- •No CR was obtained by standard chemotherapy;
- •The first induction was CR, but the duration of CR was less than 12 months;
- •No CR was obtained after the first or multiple remedial treatment;
- •Relapse twice or more;
- •The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
- •Patients is histologically diagnosed with CD7 Positive T-NHL according to The 2016 revision of the World Health Organization classification of lymphoid neoplasms.
- •r/r T-NHL, and includes any of the following conditions:
- •No response or relapse after second or more lines of chemotherapy;
- •Primary refractory ot chemotherapy;
- •Relapse after autologous stem cell transplantation;
- •According to the Lugano 2014 criteria, there is at least one evaluable tumor lesion.
- •Patients is histologically diagnosed with CD7 Positive AML according to the Clinical Practice Guidelines for Acute Myeloid Leukemia (AML) (
- •V3) by National Comprehensive Cancer Network (NCCN).
- •The diagnosis is consistent with r/r CD7 + AML, and includes any of the following conditions:
- •No CR was obtained by standard chemotherapy;
- •The first induction was CR, but the duration of CR was less than 12 months;
- •No CR was obtained after the first or multiple remedial treatment;
- •Relapse twice or more;
- •The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
排除标准
- •Patients with history of epilepsy or other central nervous system diseases;
- •Patients with prolonged QT or severe heart disease;
- •Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- •The patients with uncontrolled active infection;
- •Active hepatitis B or hepatitis C virus infection;
- •Previous application of gene therapy;
- •The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- •Those who suffer from other uncontrolled diseases are not suitable to join the study;
- •HIV infection;
- •Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
结局指标
主要结局
Dose limiting toxicity
时间窗: 28 days
Treatment Emergent Adverse Event
时间窗: 2 years
次要结局
未报告次要终点
研究者
He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
A Prospective, Open-label, Single-arm Clinical StudyRecurrent Glioblastoma MultiformeNCT04689087Sun Yat-sen University40
招募中
早期 1 期
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC PatientsMetastatic Colorectal Cancer (mCRC)NCT06621173Shanghai Changzheng Hospital9
招募中
早期 1 期
Study of CT071 Injection in High Risk Newly Diagnosed Multiple MyelomaMultiple MyelomaNCT06407947Shanghai Changzheng Hospital10
进行中（未招募）
不适用
PROACTIVE-HF IDE Trial Heart Failure NYHA Class IIIHeart Failure NYHA Class IIINCT04089059Endotronix, Inc.738
尚未招募
早期 1 期
iDAP Injection in the Treatment of Parkinson's DiseaseParkinson DiseaseNCT06583291Anhui Provincial Hospital12