IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
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
Qualifiers
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.
a) Inadequate response to standard therapy: failure to achieve complete remission (CR) after standard treatments (e.g., imatinib, corticosteroids, interferon-α, chemotherapy, etc.);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- IL-5 CAR-T cells
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov