Engineered immune cells take aim at tough leukemia
NCT ID NCT07257640
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new treatment called IL-5 CAR-T cell therapy for people with a rare and hard-to-treat blood cancer called eosinophilic leukemia. The therapy uses a patient's own immune cells, modified to target and attack cancer cells. The main goals are to check safety and see if the treatment can shrink or control the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The first affiliated hospital of medical college of zhejiang university
RECRUITINGHangzhou, Zhejiang, 310003, China
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