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

NCT07257640 | Recruiting Phase 1

• 1 other identifier: TXB2025023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Diseases; Neoplasms

Keywords

IL-5 CAR-T; Eosinophil

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Complete response (CR), and complete response with incomplete hematologic recovery (CRi)

  Up to 12 weeks after CAR-T infusion

• Duration of remission ,DOR

  Up to 1 years after CAR-T infusion

• Overall survival, OS

  Up to 1 years after CAR-T infusion

• Leukemia-Free Survival, LFS

  Up to 2 years after Treatment

Study Arms (1)

CAR-T cells

EXPERIMENTAL

IL-5 CAR-T cells

Drug: IL-5 CAR-T cells

Interventions

IL-5 CAR-T cells DRUG

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

CAR-T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥18 years;
• Diagnosis of eosinophilic leukemia (EL) established according to the WHO 2022 diagnostic criteria;
• Interleukin-5 receptor α (IL-5Rα, CD125) is expressed on ≥50% of leukemic blasts.
• 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;
• Serum total bilirubin ≤1.5 × the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN;
• Left ventricular ejection fraction (LVEF) \>50% as assessed by echocardiography;
• Peripheral oxygen saturation (SpO₂) ≥92% on room air (without supplemental oxygen);
• Estimated life expectancy \>3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• 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);
• Patients who are willing to participate in this study and who are able to understand and voluntarily sign the written informed consent form.

You may not qualify if:

• History of epilepsy or other central nervous system (CNS) disorders;
• 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;
• History of QT interval prolongation or severe cardiac disease;
• Presence of uncontrolled active infection;
• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• He Huang, MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Songmin Ying, MD

CONTACT

0571-88208002; yings@zju.edu.cn

Yongxian Hu, MD

CONTACT

057187233772; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)