IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia

Zhejiang University

Status and phase

Enrolling

Phase 1

Conditions

Neoplasms

Hematologic Diseases

Treatments

Drug: IL-5 CAR-T cells

Study type

Interventional

Funder types

Other

Identifiers

NCT07257640

TXB2025023

Details and patient eligibility

About

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.

Full description

The IL-5 CAR is composed of full length human IL-5 (hIL-5) fused to the human CD8α hinge and transmembrane domains, followed by the human 4-1BB co-stimulatory domain and the CD3ζ signaling domain. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of IL-5 CAR-T cells in patients with CD125-positive eosinophilic leukemia.

The Secondary research objectives:

To investigate the cytokinetic characteristics of IL-5 CAR-T cells in patients with CD125-positive eosinophilic leukemia.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.