KCT0009570尚未招募未知
A pilot study of AT101 (humanized anti-CD19 chimeric antigen receptor T cell) in anti-CD19 CAR T therapy-exposed patients with relapsed or refractory diffuse large B cell lymphoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Adult, age >18
- •2) Diffuse Large B-Cell Lymphoma based on WHO classification 2017
- •3) Progression after anti CD19 CART therapy
- •4) CD19 expression of biopsy after anti CD19 CART therapy
- •5) one or more Measurable lesion by Lugano 2014
- •6)The Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2
- •7) Adequate hematological, kidney, liver, lung, heart and bone marrow function without blood transfusion within two weeks prior to screening
- •8) Those with a minimum life expectancy of 12 weeks or more
- •9) In women with childbearing, clinical response tests (serum- or ure-hCG) were negatively identified during this trial
- •10) Those who have agreed in writing to participate voluntarily in this trial
排除标准
- •1) Those who have previously had a history of treating homologic autologous hemoblastitis (allogeneic HSCT)
- •2) AT101/adcidmilisers, anticancer chemotherapy/adcidms for lymphodeletion or those who are hypersensitive to tocilizumab
- •3) Those who cannot take autologous blood
- •4) Those who have received chemotherapy or radiotherapy, excluding lymphodeletion, within two weeks prior to IP administration
- •5) Persons who have not been recovered (CTCAE grade =1 or baseline) due to previous treatment
- •6) Those who have identified a condition that, at the test's discretion, may affect safety and validation during the trial period.
- •7)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 three 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
- •8) 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
- •9) 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
研究者
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