供者来源 CD117 CAR-T 细胞治疗复发/难治性急性髓系白血病

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

主要终点：Dose-limiting toxicity (DLT) · Adverse events assessed according to NCI-CTCAE v5.0 criteria · Up to 28 days after Treatment；Incidence of treatment-emergent adverse events (TEAEs) · Incidence of treatment-emergent adverse events \[Safety and Tolerability\] · Up to 2 years after Treatment
次要终点：Complete response (CR), and complete response with incomplete hematologic recovery (CRi)；Duration of remission ,DOR；Overall survival, OS；Leukemia-Free Survival, LFS

• CAR-T cells（ chimeric antigen receptor T cells） · EXPERIMENTAL · Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

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