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

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D) [Срок оценки: 28 days]
• Overall response rate (ORR) by Independent assessment [Срок оценки: 5 years]

Вторичные конечные точки (11)

• Overall response rate (ORR) by Investigator assessment [Срок оценки: 5 years]
• Duration of overall response (DOR) [Срок оценки: 5 years]
• Overall survival(OS) [Срок оценки: 5 years]
• Progression free survival (PFS) [Срок оценки: 5 years]
• Time to response (TTR) [Срок оценки: 5 years]
• Event free survival (EFS) [Срок оценки: 5 years]
• Incidence of adverse Event [Срок оценки: 5 years]
• Peak concentration (Cmax) of AT101 [Срок оценки: 5 years]
• Area under the concentration versus time curve (AUC) of AT101 [Срок оценки: 5 years]
• AT101 transgene expression [Срок оценки: 5 years]
• Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Asan Medical Center — Seoul

Публикации

• Zhang Y, Patel RP, Kim KH, Cho H, Jo JC, Jeong SH, Oh SY, Choi YS, Kim SH, Lee JH, Angelos M, Guruprasad P, Cohen I, Ugwuanyi O, Lee YG, Pajarillo R, Cho JH, Carturan A, Paruzzo L, Ghilardi G, Wang M, Kim S, Kim SM, Lee HJ, Park JH, Cui L, Lee TB, Hwang IS, Lee YH, Lee YJ, Porazzi P, Liu D, Lee Y, Kim JH, Lee JS, Yoon DH, Chung J, Ruella M. Safety and efficacy of a novel anti-CD19 chimeric antigen PMID 38066564

Идентификаторы

NCT: NCT05338931 · AbClon

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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