NCT04303520Unknown1 期
A Phase I Clinical Trial of T-Cells Targeting CD19 and CD22 for Subjects With CD19-positive Acute Lymphoblastic Leukemia
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
研究概览
简要总结
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.
详细描述
Primary Objectives
- To determine the feasibility ad safety of anti-CD19/ CD22 CAR-T cells in treating patients with CD19-positive Acute Lymphoblastic Leukemia.
Secondary Objectives
- To determine in vivo expression, dynamics and persistency of anti-CD19/CD22 CAR-T cells.
- To determine in vivo expression of CD19-positive B cells.
- To access the complete remission rate (ORR) in patients with ALL with 3 months after CD19/CD22 CAR-T cells infusion.
- To investigate the favorable CD19/CD22 CAR-T cells dose and dosage regimen for the Phase II Clinical Trial.
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
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13 Years to 70 Years, Male and female;
- •Expected survival > 12 weeks;
- •Clinical performance status of ECOG score 0-2;
- •Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions:
- •Patients received at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
- •Disease recurrence after stem cell transplantation.
- •Accessible to intravenous injection, and no white blood cell collection contraindications
- •Patients who meet the following conditions:
- •Creatinine < 2.5 mmol/l;
- •Cardiac ejection fraction>50%, no pericardial effusion and no pleural effusion (ECHO examination);
- •Baseline oxygen saturation>92%;
- •Total bilirubin≤1.5xULN;
- •ALT/AST≤2.5x normal.
- •Able to understand and sign the Informed Consent Document.
排除标准
- •Accompanied by other malignant tumor
- •Active hepatitis B, hepatitis C, syphilis, HIV infection
- •Suffering severe cardiovascular or respiratory disease
- •Any other diseases could affect the outcome of this trial
- •Any affairs could affect the safety of the subjects or outcome of this trial
- •Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment
- •Occurrence of infection uncontrolled or requiring systemic treatment 14 days prior to assignment
- •Patients who are accounted by researchers to be not appropriate for this test
- •Received CAR-T treatment or other gene therapies before assignment
- •Patients with symptoms of central nervous system
- •Subject suffering disease affects the understanding of informed consent or comply with study protocol.
研究组 & 干预措施
anti-CD19/CD22 CAR-T cells
Experimental
Administration with anti-CD19/CD22 CAR-T cells in the CD19-positive ALL patients
干预措施: anti-CD19/CD22 CAR-T cells (Biological)
anti-CD19/CD22 CAR-T cells
Experimental
Administration with anti-CD19/CD22 CAR-T cells in the CD19-positive ALL patients
干预措施: Fludarabine (Drug)
anti-CD19/CD22 CAR-T cells
Experimental
Administration with anti-CD19/CD22 CAR-T cells in the CD19-positive ALL patients
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
时间窗: 6 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
次要结局
- Duration of CAR-positive T cells in circulation(6 months)
- Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm(8 weeks)
- Total number of CAR-positive T cells infiltrated into lymphoma tissue(6 months)
研究者
研究点 (1)
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