NCT05518357

LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

An Exploratory Clinical Study on the Safety and Efficacy of LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Hebei Yanda Ludaopei Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	LILRB4 STAR-T	Subjects with relapsed/refractory acute myeloid leukemia will be enrolled in the study, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of STAR-T cells. STAR-T cells will be intravenously infused with a escalated dose of 1E6#3E6#1E7 cells/kg。

Timeline

• Start date: 2022-06-24
• Primary completion: 2022-11-15
• Completion: 2022-11-15
• First posted: 2022-08-26
• Last updated: 2023-01-12

Locations

1 site across 1 country: China