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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
IL-5 CAR-T cells
DrugEach subject receive IL-5 CAR T-cells by intravenous infusion
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: CAR-T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame
Up to 28 days after Treatment2
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame
Up to 2 years after TreatmentSecondary outcomes
1
Complete response (CR), and complete response with incomplete hematologic recovery (CRi)
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Time frame
Up to 12 weeks after CAR-T infusion2
Duration of remission ,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Time frame
Up to 1 years after CAR-T infusion3
Overall survival, OS
The time from CAR-T infusion to death due to any cause
Time frame
Up to 1 years after CAR-T infusion4
Leukemia-Free Survival, LFS
The time from CAR-T infusion torecurrence or metastasis
Time frame
Up to 2 years after TreatmentSponsors and contacts
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Source ClinicalTrials.gov