Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07257640

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

Led by Zhejiang University · Updated on 2025-12-10

20

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 6518 years
  • Diagnosis of eosinophilic leukemia established by WHO 2022 criteria
  • IL-5 receptor alpha (CD125) expressed on 6550% of leukemic blasts
  • Refractory or relapsed eosinophilic leukemia with inadequate response to standard therapy or relapse within 6 months after remission
  • Serum total bilirubin 651.5 times upper limit of normal (ULN)
  • ALT and AST liver enzymes 653 times ULN
  • Left ventricular ejection fraction (LVEF) greater than 50% as assessed by echocardiography
  • Peripheral oxygen saturation (SpO2) 6592% on room air without supplemental oxygen
  • Estimated life expectancy greater than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Women and men of childbearing potential must agree to use effective contraception before and during the study and for 6 months after treatment
  • Ability and willingness to understand and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • History of epilepsy or other central nervous system disorders
  • Positive for hepatitis B surface antigen or detectable hepatitis B virus DNA or positive for hepatitis C virus antibody or HIV antibody or positive serologic test for syphilis
  • History of QT interval prolongation or severe heart disease
  • Presence of uncontrolled active infection
  • Any condition that may increase risk or interfere with study results as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

S

Songmin Ying, MD

CONTACT

Y

Yongxian Hu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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