NCT04661020招募中2 期
Clinical Trial for the Safety and Efficacy of CD19 CAR-T Therapy for Patients With B-cell Non-Hodgkin's Lymphoma
Zhejiang University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年12月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
A Study of CD19 CAR-T Therapy for Patients With B-cell Non-Hodgkin's Lymphoma.
详细描述
This is a single arm, open-label, single-center study. This study is indicated for patients with CD19+ non-Hodgkin's lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age no less than 18, no gender limit;
- •Histologically confirmed diagnosis of HGBCL（HGBCL-NOS、HGBCL involving combined rearrangements of MYC, bcl-2 and bcl-6）DLBCL、not otherwise specified and IPI≥3;
- •Newly diagnosed B-NHL, unwilling to receive RCHOP first- or second-line chemotherapy, but willing to receive targeted drugs (such as a regimen consisting of CD20 monoclonal antibody，lenalidomide and Brutons tyrosine kinase inhibitor for two courses) as preconditioning regimens for CAR-T cell therapy;
- •Patients with PR or SD efficacy evaluated by PET-CT after two courses of tumor reduction therapy;
- •Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
- •Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- •No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
- •Estimated survival time ≥ 3 months;
- •ECOG performance status 0 to 2;
- •Patients or their legal guardians volunteer to participate in the study and sign the 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;
- •Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- •Active infection of hepatitis B virus or hepatitis C virus;
- •Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
- •Insufficient amplification capacity in response to CD3 / CD28 co-stimulus signal (<5 times) ;
- •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
Administration of CD19 CAR T-cells
Experimental
干预措施: CD19 CAR-T cells (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after CD19 targeted CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after CD19 targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- Instrumental Activities of Daily Living (IADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
- B-NHL, Overall survival (OS)(Up to 2 years after CD19 CAR-T cells infusion)
- Activities of Daily Living (ADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
- Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)(At Baseline, Month 1, 3, 6, 9 and 12)
- Hospital Anxiety and Depression Scale (HADS) score(At Baseline, Month 1, 3, 6, 9 and 12)
- B-cell Non-Hodgkin's Lymphoma (B-NHL), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- B-NHL, Event-free survival (EFS)(Up to 2 years after CD19 CAR-T cells infusion)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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