Clinical Trials Directory

Trials / Completed

CompletedNCT05548088

LILRB4 STAR-T Cells in the Treatment of R/R AML/CMML

An Exploratory Clinical Study of the Safety and Efficacy of LILRB4 STAR-T Cells for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia/Chronic Granulocytic-Mononocytic Leukemia

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Peking University People's Hospital · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

This study is an exploratory study to evaluate the safety, tolerability, and efficacy of LILRB4 STAR-T cells in relapsed and refractory acute myeloid leukemia/Chronic Granulocytic-Mononocytic Leukemia subjects.

Detailed description

This study will recruit LILRB4 positive AML/Chronic Granulocytic-Mononocytic Leukemia 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, 6E6, 1E7 cells/kg.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 Disease response, CR rate, ORR, RFS, EFS, OS, PK, PD and ADA.

Conditions

Interventions

TypeNameDescription
BIOLOGICALLILRB4 STAR-T cellsSubjects 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, -4and-3followed 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
2023-05-25
Primary completion
2024-08-03
Completion
2024-08-03
First posted
2022-09-21
Last updated
2025-03-05

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05548088. Inclusion in this directory is not an endorsement.