Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

Официальное название

A Clinical Study on the Safety and Effectiveness of Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

Обзор

A Clinical Study on the Safety and Effectiveness of donor derived CD19 CAR-T Cells in the treatment of R/R B-cell acute lymphoblastic leukemia

Подробное описание

In this study, 15 patients with relapsed refractory B-cell acute lymphoblastic leukemia were proposed to undergo CD19 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19 CAR-T Cells therapy for relapsed refractory B-cell acute lymphoblastic leukemia; At the same time, on the basis of expanding the sample size, more safety data on CD19 CAR-T Cells treatment for relapsed refractory B-cell acute lymphoblastic leukemia were accumulated.

Вмешательства

• Биопрепарат CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells injection
  Each subject receive CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells by intravenous infusion

Первичные конечные точки

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

Вторичные конечные точки (3)

• Duration of remission ,DOR [Срок оценки: Up to 1 years after CAR-T infusion]
• Overall survival, OS [Срок оценки: Up to 2 years after Treatment]
• Event-free survival (EFS) [Срок оценки: Up to 1 years after CAR-T infusion]

Критерии участия

Критерии включения

• 1\. Age ≥18 years old, gender unlimited;
• 2\. Abnormal B cell immunotyping was CD19 positive;
• 3\. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping;
• 4\. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions:

• No CR was obtained after standard chemotherapy;
• CR was induced for the first time, but the duration of CR was less than 12 months;
• R/R B-ALL that does not work after the first or more remedial treatments;
• Two or more relapses;
• 5\. The researchers believed that the patient had been adequately treated, such as auto-HSCT, auto-CART could not be prepared or preparation failed. Autologous CAR-T preparation failure was defined as including too few autologous lymphocytes (<1×109) or insufficient expansion during preparation or failure to meet the release criteria;
• 6\. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L);
• 7\. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin ≧60g/L;
• 8\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%;
• 9\. The estimated survival is more than 3 months;
• 10\. ECOG score 0-2;
• 11\. Women and men who are fertile must consent to the use of appropriate contraception before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known, with unknown risks);
• 12\. Subjects who are willing to participate in the study are able to understand and have the ability to sign informed consent.

Критерии исключения

• 1\. Known allergies to research preconditioning measures, etc;
• 2\. People with a history of epilepsy or other central nervous system disorders;
• 3\. People with a history of prolonged QT or severe heart disease;
• 4\. Less than 100 days after receiving allogeneic hematopoietic stem cell transplantation;
• 5\. Hiv-infected person;
• 6\. Persons with active hepatitis B or C virus; Those who are not cured have active infections;
• 7\. Insufficient amplification ability (< 5x) in response to CD3 / CD28 costimulatory signals;
• 8\. Combined use of systemic steroids (e.g., prednisone ≥20mg) within 3 days prior to screening, except for ongoing or intermittent use of topical, inhaled or intranasal steroids within 2 weeks or at present; Or have systemic diseases that require long-term use of immunological agents;
• 9\. Patients who received anti-cancer chemotherapy or other drugs within 2 weeks prior to screening;
• 10\. Any situation that the investigator believes may increase the risk of the subjects or interfere with the study results.

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: NCT06793241 · TXB2024011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗