Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
详细描述
This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥15 years old
- •Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
- •The immunophenotype of leukemia cells were CD19 and CD22 positive
- •Ph- or Ph- like negative
- •Anticipated survival time more than 12 weeks;
- •Those who voluntarily participated in this trial and provided informed consent.
排除标准
- •History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •Pregnant (or lactating) women;
- •Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- •Active infection of hepatitis B virus or hepatitis C virus;
- •Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
- •Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
- •Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
- •Other uncontrolled diseases that were not suitable for this trial;
- •Patients with HIV infection;
- •Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
研究组 & 干预措施
CAR-T therapy
Administration of CD19 and CD22 CAR T-cells
干预措施: CAR-T cells targeting CD19 and CD22 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after CAR-T cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after CAR-T cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- Complete Remission Rate(up to 28 days after CAR-T cells infusion)
- Overall survival (OS)(Up to 2 years after CD19 CAR-T cells infusion)
- Leukemia-free survival (LFS)(Up to 2 years after CD19 CAR-T cells infusion)
- Quality of life(At Baseline, Month 1, 3, 6, 9 and 12)
研究者
He Huang
Professor
Zhejiang University