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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Hematologic Diseases
• Intervention / Treatment: Drug: IL-5 CAR-T cells

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yongxian Hu, MD; Phone Number: 057187233772; Email: huyongxian2000@aliyun.com
• Study Contact Backup: Name: Songmin Ying, MD; Phone Number: 0571-88208002; Email: yings@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The first affiliated hospital of medical college of zhejiang university
      • Contact: He Huang, MD; Phone Number: 057187233772; Email: hehuangyu@126.com
      • Contact: Yongxian Hu, MD; Phone Number: 057187233772; Email: huyongxian2000@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAR-T cells; IL-5 CAR-T cells	Drug: IL-5 CAR-T cells; Each subject receive IL-5 CAR T-cells by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events [Safety and Tolerability]	Up to 2 years after Treatment
Dose-limiting toxicity (DLT)	Adverse events assessed according to NCI-CTCAE v5.0 criteria	Up to 28 days after Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival, OS	The time from CAR-T infusion to death due to any cause	Up to 1 years after CAR-T infusion
Duration of remission ,DOR	The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion	Up to 1 years after CAR-T infusion
Complete response (CR), and complete response with incomplete hematologic recovery (CRi)	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).	Up to 12 weeks after CAR-T infusion
Leukemia-Free Survival, LFS	The time from CAR-T infusion torecurrence or metastasis	Up to 2 years after Treatment

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Principal Investigator: He Huang, MD, First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Eosinophil; IL-5 CAR-T
• Additional Relevant MeSH Terms: Hemic and Lymphatic Diseases; Neoplasms; Hematologic Diseases
• Other Study ID Numbers: TXB2025023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No