CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL

Официальное название

A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL

Обзор

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.

Подробное описание

In this study, 20 patients with relapsed refractory B-cell ALL and B-cell NHL were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for relapsed refractory B-cell ALL and B-cell NHL; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for relapsed refractory B-cell ALL and B-cell NHL were accumulated, including rare and delayed complications.

Вмешательства

• Биопрепарат CD19-BAFF Targeted CAR T-cells
  Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Up to 28 years after Treatment]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 2 years after Treatment]

Вторичные конечные точки (4)

• Overall response rate ,ORR [Срок оценки: Up to 12 weeks after CAR-T infusion]
• Duration of remission ,DOR [Срок оценки: Up to 1 years after CAR-T infusion]
• Event-free survival, EFS [Срок оценки: Up to 1 years after CAR-T infusion]
• Overall survival, OS [Срок оценки: Up to 1 years after CAR-T infusion]

Критерии участия

Критерии включения

• 1\. Gender unlimited，18< Age;
• 2\. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma
• 3\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):

• CR not achieved after standardized chemotherapy;
• CR achieved following the first induction, but CR duration is less than 12 months;
• Ineffectively after first or multiple remedial treatments;
• 2 or more relapses;
• 4\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (by morphology), and/or >1% (by flow cytometry);
• 5\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
• 6\. Relapsed or refractory B-NHL (meeting one of the following conditions):

• No response or relapse after second-line or above chemotherapy regimens;
• Primary drug resistance;
• Relapse after auto-HSCT;
• 7\. At least one assessable tumor lesion per Lugano 2014 criteria;
• 8\. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
• 9\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
• 10\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
• 11\. Estimated survival time ≥ 3 months;
• 12\. ECOG performance status 0 to 2;
• 13\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Критерии исключения

• 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• 3\. Pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion
• 4\. Patients with HIV infection;
• 5\. Active infection of hepatitis B virus or hepatitis C virus;
• 6\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 7\. Other uncontrolled diseases that were not suitable for this trial;
• 8\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;
• 9\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

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

Китай · 1 центр

• The first affiliated hospital of medical college of zhejiang university — Ханчжоу

Идентификаторы

NCT: NCT06346912 · TXB2023022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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