CELL INTELLIGENCE · 肿瘤细胞治疗研究

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

主要终点：Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D) · Phase I: Tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials · 28 days；Overall response rate (ORR) by Independent assessment · Phase II: Proportion of subjects whose best overall response in tumor evaluation was evaluated as a complete response or a partial response · 5 years
次要终点：Overall response rate (ORR) by Investigator assessment；Duration of overall response (DOR)；Overall survival(OS)；Progression free survival (PFS)；Time to response (TTR)；Event free survival (EFS)；Incidence of adverse Event；Peak concentration (Cmax) of AT101

• AT101(Anti-CD19 Chimeric Antigen Receptor T cell) · EXPERIMENTAL · Anti-CD19 Chimeric Antigen Receptor T cell

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