None listed
Conditions
Interventions
Genetic : AT101 injection , once
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate | — |
Countries
Korea, Republic of
Contacts
Public ContactYounglan Hong
Asan Medical Center
Outcome results
None listed