Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

Официальное название

A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

Обзор

A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL

Подробное описание

In this study, 30 patients with relapsed refractory T-ALL were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-ALL; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-ALL were accumulated.

Вмешательства

• Биопрепарат CD5 CAR T-cells
  Each subject receive CD5+ T-ALL 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 (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]
• Progression Free Survival, PFS [Срок оценки: Up to 2 years after Treatment]
• Overall survival, OS [Срок оценки: Up to 1 years after CAR-T infusion]

Критерии участия

Критерии включения

• 1\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
• 2\. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:

• No CR after standard chemotherapy;
• The first induction reaches CR, but CR ≤ 12 months;
• Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;

c.Multiple recurrences.

• 3\. CD5 expression rate was >90%;
• 4\. Number of blasts in the bone marrow (protolychic + larvae) >5% (morphology) and/or >1% (flow cytometry);
• 5\. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
• 6\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
• 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);
• 8.Estimated life expectancy of minimum of 12 weeks;
• 9.ECOG 0-2;
• 10.Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
• 11\. Those who voluntarily participated in this trial and provided informed consent;

Критерии исключения

• 1.Patients with the history of epilepsy or other CNS disease;
• 2\. Patients with prolonged QT interval time or severe heart disease;
• 3\. Active infection of hepatitis B virus, C virus or hepatitis E virus;
• 4\. Active infection with no cure;
• 5\. Before using any gene therapy products;
• 6\. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:

• treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone < 10 mg/d or an equivalent dose of the drug);
• received within 72 hours of small molecule targeted therapy;
• 2 weeks received systemic chemotherapy except (pretreatment);
• four weeks received radiotherapy;
• 7\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 8\. Any unsuitable to participate in this trial judged by the investigator;
• 9\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial 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: NCT06633354 · TXB2024014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗