IL-5 CAR-T cells: Each subject receive IL-5 CAR T-cells by intravenous infusion
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose-limiting toxicity (DLT) — Up to 28 days after Treatment Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years after Treatment Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Trial sites (1)
Facility
City
Region
Status
The first affiliated hospital of medical college of zhejiang university
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.