Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia

Официальное название

Donor Derived CD117 CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Обзор

A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia

Подробное описание

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD117 CAR-T Cell in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 15-50 participants in this trial.

Вмешательства

• Биопрепарат CD117 CAR T-cells
  Each subject receive CD117 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)

• Complete response (CR), and complete response with incomplete hematologic recovery (CRi) [Срок оценки: Up to 12 weeks after CAR-T infusion]
• Duration of remission ,DOR [Срок оценки: Up to 1 years after CAR-T infusion]
• Overall survival, OS [Срок оценки: Up to 1 years after CAR-T infusion]
• Leukemia-Free Survival, LFS [Срок оценки: Up to 2 years after Treatment]

Критерии участия

Критерии включения

• 1\. Patients with a histologically or immunophenotypically confirmed diagnosis of CD117-positive Acute Myeloid Leukemia (AML).
• 2\. Diagnosis must meet the 2016 WHO classification criteria for AML and fulfill the definitions for relapsed or refractory disease per the \*Chinese Guidelines for the Diagnosis and Management of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition)\*, with no available suitable standard therapeutic options or registered clinical trials.
• a). Relapsed AML: Defined as the reappearance of leukemic blasts in the peripheral blood, bone marrow blast count >5% (when assessed morphologically, after excluding regenerative changes post-consolidation chemotherapy), or development of extramedullary disease after achieving a Complete Remission (CR).
• b). Refractory AML (meeting at least one criterion): Failure to achieve CR following two cycles of standard induction therapy in newly diagnosed patients; relapse within 12 months after CR following consolidation therapy; relapse beyond 12 months that fails to respond to conventional salvage chemotherapy; ≥2 relapses; or persistent extramedullary leukemia.
• 3\. Presence of >5% bone marrow blasts (by morphology) and/or >1% (by flow cytometric analysis).
• 4\. Total bilirubin ≤1.5 × ULN (≤51 μmol/L) ALT and AST ≤3 × ULN Serum creatinine ≤1.5 × ULN (≤176.8 μmol/L)
• 5\. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.
• 6\. Oxygen saturation ≥92% on room air.
• 7\. Life expectancy ≥3 months.
• 8\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• 9\. For patients of childbearing potential: Agreement to use highly effective contraception from screening, throughout the study treatment period, and for at least 6 months after the cell infusion (due to unknown risks to the fetus).
• 10\. Voluntary participation, understanding of the study procedures, and provision of written informed consent by the patient or their legally authorized representative.

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 with no cure;
• 4\. Active infection of hepatitis B virus or C virus ;
• 5\. Before using any gene therapy products;
• 6\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 7\. Suffering from other uncontrolled diseases that the researchers consider unsuitable for joining;
• 8\. Infected with AIDS virus;
• 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: NCT07144020 · TXB2024010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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