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Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Bu Faz 1/2 (Phase 1/2) çalışma, CD19'u hedefleyen kimerik antijen reseptörlü T hücresi (CAR-T) tedavisi AT101'i, tekrarlayan veya tedaviye yanıt vermeyen B hücreli non-Hodgkin lenfoma (B-cell non-Hodgkin lymphoma) hastalarında inceliyor. Çalışma, güvenlik ve tolere edilebilirliğe dayanarak en yüksek tolere edilen dozu ve sonraki aşama için önerilen dozu belirlemeyi amaçlıyor. Standart tedavilerin uygun olmadığı veya hastalığın bu tedavilere rağmen ilerlediği hastalar katılabiliyor; çalışma hâlâ katılımcı alıyor.
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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