NCT07257640

IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia

The Safety and Efficay Investigation of IL-5 CAR-T Cell Therapy for Patients With Refractory/Relapsed Eosinophilic Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The IL-5 CAR is composed of full length human IL-5 (hIL-5) fused to the human CD8α hinge and transmembrane domains, followed by the human 4-1BB co-stimulatory domain and the CD3ζ signaling domain. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy. The Main research objectives: To evaluate the safety and efficacy of IL-5 CAR-T cells in patients with CD125-positive eosinophilic leukemia. The Secondary research objectives: To investigate the cytokinetic characteristics of IL-5 CAR-T cells in patients with CD125-positive eosinophilic leukemia.

Conditions

• Hematologic Diseases
• Neoplasms

Interventions

Type	Name	Description
DRUG	IL-5 CAR-T cells	Each subject receive IL-5 CAR T-cells by intravenous infusion

Timeline

• Start date: 2025-11-30
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2025-12-02
• Last updated: 2025-12-10

Locations

1 site across 1 country: China