NCT03229876暂停不适用
A Safety and Efficacy Study of CD19-UCART (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor) in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Bioray Laboratories2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicities (DLTs) occurence
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ascending doses of CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.
详细描述
CD19-UCART is a kind of "off-the-shelf" product originated from health donor's PBMC.This is a open-label, dose estilation study to evaluate the safety and anti-tumor efficacy of CD19-UCART in the treatment of relapsed or refractory B-cell hematological malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participating in this clinical study and signing the informed consent form; The estimated survival period is at least one month;
- •No other serious cardiopulmonary diseases, and normal liver and kidney functions (except for subjects with tumor lesions in their liver and kidneys);
- •Failure of T cell isolation during autologous CART preparation or failure of CART amplification or failure to complete apheresis or disease progression resulting in patients not benefiting from autologous CAR-T cell therapy; Or: T cell percentage in PBMC of peripheral blood ≤ 10%; Or the disease is not effectively controlled within one month after autologous CAR-T transfusion, and the patient cannot receive CAR-T transfusion again;
- •Flow cytometry within two months demonstrated positive expression of CD19 in the tumor (positive rate 50%-90%; Or biopsy ≥ 50% within 6 months; Or obtaining a biopsy again);
- •Hematological indicators: 1) WBC count ≥ 1.5× 10^9/L; Absolute value of neutrophils ≥ 0.8× 10^9/L; Lymphocyte count ≥0.1×10^9/L;2) Hemoglobin ≥ 60g/L;3) Platelet count ≥20×10^9/L;
- •Biochemical indicators (except for subjects with tumor foci in liver and kidney): Total bilirubin (TBIL)≤1.5 times the Upper Limits of Normal (ULN); AST and ALT≤1.5 *ULN; Scr and BUN)≤1.5*ULN; Biochemical indicators in subjects with liver and kidney invasion should meet: Total bilirubin (TBIL)≤5 *ULN;AST and ALT≤5*ULN; Scr and BUN ≤ 5*ULN;
- •Cardiac function: Good hemodynamic stability, and the left ventricular ejection fraction (LVEF) ≥ 55%;
- •Serum viral EBV-DNA, CMV-DNA, HIV antibody and syphilis antibody, HBV, HCV virus quantification were all negative;
- •ECOG activity status score: 0-2 points;
- •Female subjects must have access to effective contraceptive measures (e.g., oral prescription contraceptives, injectable contraceptives, intrauterine devices, double blocking, contraceptive patches, male partner sterilizations) throughout the study period; Serum or urine pregnancy test results must be negative at screening and throughout the study;
- •Willing to comply with the rules established in this protocol;
- •Patients with relapsed/refractory CD19-positive acute B-cell leukemia (B-ALL, with the age of 1-60 years) or relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL, with the age of 5-65 years).
排除标准
- •Pregnant or lactating women;
- •The following drugs or treatments should be excluded:High-dose glucocorticoids were used within 72h prior to UCAR-T infusion, except for physiological alternative therapies;Allogeneic cell therapies such as donor lymphocyte transfusion within 6 weeks prior to UCAR-T transfusion;GVHD treatment;
- •Single extramedullary relapse B-ALL;
- •Suffering from severe mental disorder;
- •Active autoimmune diseases requiring immunotherapy;
- •History of other malignant tumors;
- •Patients with severe cardiovascular disease;
- •Organ function is in the following abnormalities;
- •Total bilirubin > 1.5 times the upper limit of normal unless the patient is Gilbert's syndrome;
- •Partial thromboplastin time or activated partial thromboplastin time or international normalized ratio >1.5*ULN；in the absence of anticoagulant therapy;
- •There is an active infectious disease or any major infectious event requiring high-level antibiotics;
- •Any condition that, in the opinion of the investigator, may increase the subject's risk or interfere with the test results.
结局指标
主要结局
Dose Limiting Toxicities (DLTs) occurence
时间窗: Baseline up to 35 days after T cell infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- Day 90 progression-free survival(Assessed up to 3 months)
- Objective Response Rate(At 12 weeks, and overall)
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
1 期
Safety and Efficacy Evaluation of Next-generation CD19-UCARTNon Hodgkin LymphomaAcute Lymphoblastic LeukemiaNCT05381181Bioray Laboratories20
招募中
1 期
Efficacy and Safety of CD19 UCAR T Cells in Refractory Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT06691152The Children's Hospital of Zhejiang University School of Medicine18
招募中
1 期
CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT06349343Wuhan Union Hospital, China20
进行中（未招募）
不适用
A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)Relapsed or Refractory B-cell Malignancy(NHL/ALL)NCT04933825EdiGene (GuangZhou) Inc.18
已完成
1 期
CD19-CART Treatment for ALLAcute LeukemiaNCT03232619Bioray Laboratories4