NCT04662294招募中早期 1 期
Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases
Zhejiang University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年11月18日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases
详细描述
This is a single arm, open-label, single-center study. This study is indicated for CD 70 CAR T for patients with CD70 positive malignant hematologic diseases. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 108 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
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria only for AML:
- •Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
- •Relapsed or refractory CD70+ AML (meeting one of the following conditions):
- •CR not achieved after standardized chemotherapy;
- •CR achieved following the first induction, but CR duration is less than 12 months;
- •Ineffectively after first or multiple remedial treatments;
- •2 or more relapses;
- •The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);
- •Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
- •Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- •No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
- •Estimated survival time ≥ 3 months;
- •ECOG performance status 0 to 2;
- •Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
- •Inclusion criteria only for NHL:
- •No gender and age limit;
- •Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
- •Relapsed or refractory CD70+ NHL (meeting one of the following conditions):
- •No response or relapse after second-line or above chemotherapy regimens;
- •Primary drug resistance;
- •Relapse after auto-HSCT;
- •At least one assessable tumor lesion per Lugano 2014 criteria
- •Inclusion criteria only for MM:
- •Histologically confirmed diagnosis of CD70 multiple myeloma (MM)：
- •According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent / refractory multiple myeloma
- •Cases with recurrent positive minimal residual disease;
- •Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
- •No gender and age limit;
- •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 indoorair is ≥ 92%;
- •Estimated survival time ≥ 3 months;
- •ECOG performance status 0 to 2;
- •Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
- •Common inclusion criteria :
- •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;
- •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 geneticallymodified 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. -
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after CD70 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 CD70 targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- Acute Myeloid Leukemia (AML), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- AML, Overall survival (OS)(Up to 2 years after CD70 CAR-T cells infusion)
- AML, Event-free survival (EFS)(Up to 2 years after CD70 CAR-T cells infusion)
- Non-Hodgkin's lymphoma (NHL), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- Multiple myeloma (MM), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- MM, Overall survival (OS)(Up to 2 years after CD70 CAR-T cells infusion)
- Quality of life(At Baseline, Month 1, 3, 6, 9 and 12)
- NHL, Event-free survival (EFS)(Up to 2 years after CD70 CAR-T cells infusion)
- NHL, Overall survival (OS)(Up to 2 years after CD70 CAR-T cells infusion)
- MM, Event-free survival (EFS)(Up to 2 years after CD70 CAR-T cells infusion)
- Activities of Daily Living (ADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
- Instrumental Activities of Daily Living (IADL) score(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)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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