Overview
Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.
Description
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).
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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