Menu
Recruiting NCT07257640

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

Phase I Interventional Hematologic Diseases Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IL-5 CAR-T cells.
Who it may be relevant to
Registry conditions: Hematologic Diseases, Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Safety and Efficay Investigation of IL-5 CAR-T Cell Therapy for Patients With Refractory/Relapsed Eosinophilic Leukemia

Overview

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.

Detailed 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.

Interventions

  • Drug IL-5 CAR-T cells
    Each subject receive IL-5 CAR T-cells by intravenous infusion

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: Up to 28 days after Treatment]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after Treatment]
Secondary outcome measures (4)
  • Complete response (CR), and complete response with incomplete hematologic recovery (CRi) [Time frame: Up to 12 weeks after CAR-T infusion]
  • Duration of remission ,DOR [Time frame: Up to 1 years after CAR-T infusion]
  • Overall survival, OS [Time frame: Up to 1 years after CAR-T infusion]
  • Leukemia-Free Survival, LFS [Time frame: Up to 2 years after Treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The first affiliated hospital of medical college of zhejiang university — Hangzhou

Identifiers

NCT: NCT07257640 · TXB2025023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗