IL-5 CAR-T 细胞治疗复发/难治性嗜酸性粒细胞白血病

Inclusion Criteria:

* 1.Male or female patients aged ≥18 years;
* 2.Diagnosis of eosinophilic leukemia (EL) established according to the WHO 2022 diagnostic criteria;
* 3.Interleukin-5 receptor α (IL-5Rα, CD125) is expressed on ≥50% of leukemic blasts.
* 4.Meet any of the following criteria for refractory/relapsed eosinophilic leukemia:
* a) Inadequate response to standard therapy: failure to achieve complete remission (CR) after standard treatments (e.g., imatinib, corticosteroids, interferon-α, chemotherapy, etc.);
* b) Disease progression/relapse within 6 months after achieving remission;
* 5.Serum total bilirubin ≤1.5 × the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN;
* 6.Left ventricular ejection fraction (LVEF) \>50% as assessed by echocardiography;
* 7.Peripheral oxygen saturation (SpO₂) ≥92% on room air (without supplemental oxygen);
* 8.Estimated life expectancy \>3 months;
* 9.Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* 10.Women and men of childbearing potential must agree to use appropriate, effective contraception prior to study entry, throughout the study period, and for 6 months after cell infusion (the safety of this therapy for unborn children is unknown and may pose potential risks);
* 11.Patients who are willing to participate in this study and who are able to understand and voluntarily sign the written informed consent form.

Exclusion Criteria:

* 1.History of epilepsy or other central nervous system (CNS) disorders;
* 2.Presence of any of the following:Hepatitis B surface antigen (HBsAg)-positive; Any of HBeAg, HBeAb, or HBcAb positive and detectable hepatitis B virus (HBV) DNA in peripheral blood above the lower limit of detection; Hepatitis C virus (HCV) antibody-positive; Human immunodeficiency virus (HIV) antibody-positive; Positive serologic test for syphilis;
* 3.History of QT interval prolongation or severe cardiac disease;
* 4.Presence of uncontrolled active infection;
* 5.Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the interpretation of the study 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 · EXPERIMENTAL · IL-5 CAR-T cells

This is an open-label, single-arm clinical study designed to evaluate the efficacy and safety of IL-5 CAR-T cell therapy in the treatment of patients with CD125-positive eosinophilic leukemia.