NCT05338931招募中1 期
An Open-label, Single-arm, Multi-center, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of AT101 (Anti-CD19 Chimeric Antigen Receptor T Cell) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
AbClon1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D)
研究概览
简要总结
Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.
详细描述
Determine the maximum tolerant dose (MTD) based on the safety and tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials for patients with recurrent or non-reactive B cell non-Hodgkin lymphoma (B-cell NHL).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •B cell non-Hodgkin lymphoma based on WHO classification 2017
- •incompatible with existing standard therapies or have had disease progression, and whose standard therapies do not currently have available standard therapies due to reasons such as intolerance/inadequacies or rejection
- •The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •adequate hematological, kidney, liver, lung, heart and bone marrow function without blood transfusion within two weeks prior to screening
- •Those with a minimum life expectancy of 12 weeks or more
- •In women with childbearing, clinical response tests (serum- or ure-hCG) were negatively identified during this trial
- •Those who have agreed in writing to participate voluntarily in this trial
排除标准
- •Those who have previously had a history of treating homologic autologous hemoblastitis (allogeneic HSCT)
- •At101/adcidmilisers, anticancer chemotherapy/adcidms for lymphodeletion or those who are hypersensitive to tocilizumab
- •Those who cannot take autologous blood
- •Those who have received chemotherapy or radiotherapy, excluding lymphodeletion, within two weeks prior to IP administration
- •Persons who have not been recovered (CTCAE grade ≤1 or baseline) due to previous treatment
- •Those who have identified a condition that, at the test's discretion, may affect safety and validation during the trial period.
- •Those who have identified the following forces at the time of screening:
- •Those who have been clinically aware of heart disease within 6 months prior to screening
- •Those identified as thromboembolic disease, pulmonary embolism or bleeding bleeding diatheses within 6 months prior to screening
- •Those who have identified a history of malignant tumors other than B-cell non-Hodgkin's lymphoma within five years prior to screening
- •Those who have undergone major surgery within 4 weeks prior to screening
- •Those who have undergone non-critical surgery within two weeks prior to screening
- •Childbearing women or men who do not have the will to use effective contraception for a longer period of time, either 12 months after clinical trial period and AT101 administration or when AT101 in the body is not identified
- •Those who have been administered or applied to other IP/ID within 4 weeks of screening
- •Those who are addicted to alcohol and/or medication
- •Those who are unfit or unable to participate in this trial when judged by PI
研究组 & 干预措施
AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
Experimental
Anti-CD19 Chimeric Antigen Receptor T cell
干预措施: AT101(Anti-CD19 Chimeric Antigen Receptor T cell) (Drug)
结局指标
主要结局
Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D)
时间窗: 28 days
Phase I: Tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials
Overall response rate (ORR) by Independent assessment
时间窗: 5 years
Phase II: Proportion of subjects whose best overall response in tumor evaluation was evaluated as a complete response or a partial response
次要结局
- Peak concentration (Cmax) of AT101(5 years)
- Overall response rate (ORR) by Investigator assessment(5 years)
- Progression free survival (PFS)(5 years)
- Duration of overall response (DOR)(5 years)
- Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase(5 years)
- Overall survival(OS)(5 years)
- Time to response (TTR)(5 years)
- Event free survival (EFS)(5 years)
- Incidence of adverse Event(5 years)
- AT101 transgene expression(5 years)
- Area under the concentration versus time curve (AUC) of AT101(5 years)
研究者
研究点 (1)
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