Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT05518357
Brief Summary:
This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of LILRB4 STAR-T cells in relapsed/refractory acute myeloid leukemia subjects.
Detailed Description:
This study will recruit LILRB4 positive AML subjects,and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of LILRB4 STAR-T cells. LILRB4 STAR-T cells will be intravenously infused with a escalated dose of 1E6、3E6、1E7 cells/kg.The purpose of current study is to evaluate the clinical safety and tolerability of LILRB4 STAR-T cells therapy in patients with refractory and relapsed AML.Safety and efficacy of LILRB4 STAR-T cells therapy will be monitored.The primary endpoint of the study is to observe DLT, AE, SAE, CRS and ICANS. Secondary objectives are to observe the efficacy of LILRB4 STAR-T cells, including RFS, EFS and OS, and PK.
Study:
NCT05518357
Study Brief:
Protocol Section:
NCT05518357