Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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