NCT05739409

LILRB4 STAR-T Cell Therapy for Monocytic Leukemia

An Exploratory Clinical Study on the Safety and Efficacy of LILRB4 STAR-T Cells in the Treatment of Monocytic Leukemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 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 Monocytic Leukemia subjects.

Detailed description

This study will recruit LILRB4-positive monocytic leukemia subjects who will receive cyclophosphamide and fludarabine on days -5 to -3 prior to cell infusion, followed by LILRB4 STAR-T cells. The primary objective of the study was to evaluate the safety and tolerability of LILRB4 STAR-T cells in subjects with monocytic leukemia. The secondary objective was to evaluate the therapeutic efficacy, pharmacodynamics and pharmacokinetics of LILRB4 STAR-T cells.

Conditions

• Acute Myelogenous Leukemia
• Chronic Myelomonocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	LILRB4 STAR-T cells injection	The study population was relapsed/refractory acute myeloid leukemia and chronic myelomonocytic leukemia.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#6E6#1E7 cells/kg

Timeline

• Start date: 2023-02-16
• Primary completion: 2023-05-09
• Completion: 2023-05-09
• First posted: 2023-02-22
• Last updated: 2026-02-11

Locations

2 sites across 1 country: China