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New treatment option for Hematologic Diseases
Official title IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia
ClinicalTrials.gov ID: NCT07257640
What this study is testing
What is IL-5 CAR-T cells?
IL-5 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematologic diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 11.Patients who are willing to participate in this study and who are able to understand and voluntarily sign the written informed consent form.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.