Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

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

Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.

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).

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:

  1. Those who have been clinically aware of heart disease within 6 months prior to screening
  2. Those identified as thromboembolic disease, pulmonary embolism or bleeding bleeding diatheses within 6 months prior to screening
  3. Those who have identified a history of malignant tumors other than B-cell non-Hodgkin's lymphoma within five years prior to screening
  4. Those who have undergone major surgery within 4 weeks prior to screening
  5. 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