A pilot study of AT101 in anti-CD19 CAR T therapy-exposed patients with relapsed or refractory diffuse large B cell lymphoma
- Conditions
- Neoplasms
- Registration Number
- KCT0009570
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events
- Secondary Outcome Measures
Name Time Method complete response rate