NCT04609241尚未招募早期 1 期
Clinical Trial for the Safety and Efficacy of Murine CD79b CAR-T Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
Zhejiang University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年11月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
A study of CD79b CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia and 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 relapsed or refractory Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 72 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only For B-ALL
- •No gender or age limit
- •Histologically confirmed diagnosis of CD69b+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
- •Relapsed or refractory CD123+ 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);
- •Philadelphia chromosome negative(Ph-) subjects; Ph+ subjects who cannot tolerate tyrosine kinase inhibitor (TKI) treatment or who do not respond to two kinds of TKI treatment;
- •Only For B-NHL
- •No gender or 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 B-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
- •For both B-ALL and B-NHL
- •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.
排除标准
- •History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
- •Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
- •Pregnant (or lactating) women;
- •Patients with severe active infections (excluding simple urinarytractinfectionand 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 ofpatients or interfere with the results of study.
研究组 & 干预措施
Administration of CD79b CAR-T Cell
Experimental
干预措施: CD79b 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 CD79b 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 CD79b targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- ALL, Event-free survival (EFS)(Up to 2 years after CD79b CAR-T cells infusion)
- Acute Lymphoblastic Leukemia (ALL), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- ALL, Overall survival（OS）(Up to 2 years after CD79b CAR-T cells infusion)
- B-cell Non-Hodgkin's Lymphoma（B-NHL）, Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- B-NHL, Overall survival（OS）(Up to 2 years after CD79b CAR-T cells infusion)
- Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)(At Baseline, Month 1, 3, 6, 9 and 12)
- B-NHL, Event-free survival (EFS)(Up to 2 years after CD79b 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)
Loading locations...
相似试验
招募中
早期 1 期
A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological MalignanciesNon-Hodgkin Lymphoma of Soft TissueAcute Lymphoblastic LeukemiaNCT04532281Zhejiang University120
招募中
早期 1 期
A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHLNon-hodgkin Lymphoma,B CellAcute Lymphoblastic LeukemiaNCT04532268Zhejiang University72
招募中
早期 1 期
CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHLAcute Lymphoblastic Leukemia,B-CellNon-hodgkin Lymphoma,B CellNCT06346912Zhejiang University20
招募中
早期 1 期
APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple MyelomaMultiple Myeloma in RelapseMultiple Myeloma, RefractoryNCT04657861Zhejiang University36
招募中
1 期
BCMA-CD19 cCAR T Cell Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)Relapsed/Refractory, Systemic Lupus Erythematosus (SLE)NCT05474885iCell Gene Therapeutics15