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Clinical Trial Summary

This is a multi-center, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).


Clinical Trial Description

This trial is a multi-center, open label, single-arm, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult (aged 18~65 years old) patients with r/r B-cell ALL. The phase I part of the trial is to evaluate the safety, optimal dose of HY004, Pharmacokinetics/Pharmacodynamics(PK/PD)and preliminary efficacy in the treatment of Adult patients with r/r B-cell ALL. The phase II part of the trial is to evaluate the efficacy and safety of HY004 in in the treatment of Adult patients with r/r B-cell ALL. The study includes screening, pre-treatment (Cell Product manufacture & lymphodepletion), HY004 infusion, safety and efficacy follow-up, and survival follow-up. All subjects who have received HY004 infusion will be followed for up to 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06009107
Study type Interventional
Source Juventas Cell Therapy Ltd.
Contact JunYin Yu PM
Phone +86-010-65960098
Email yujunyin@juventas.cn
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date August 31, 2024
Completion date December 30, 2026

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