NCT07257640 IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia
| NCT ID | NCT07257640 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zhejiang University |
| Condition | Hematologic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-30 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-11-30 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
He Huang, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT07257640 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07257640 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07257640 currently recruiting?
Yes, NCT07257640 is actively recruiting participants. Contact the research team at yings@zju.edu.cn for enrollment information.
Where is the NCT07257640 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07257640 clinical trial?
NCT07257640 is sponsored by Zhejiang University. The principal investigator is He Huang, MD at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 20 participants.