NCT05548088

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

Completed Phase 1 Last updated 5 March 2025

What this trial tests

Phase 1 trial testing LILRB4 STAR-T cells in Relapsed/Refractory Acute Myeloid Leukemia and Chronic Granulocytic-Mononocytic Leukemia in 11 participants. Completed in 3 August 2024.

Timeline

25 May 2023

Primary endpoint
3 August 2024

3 August 2024

Quick facts

Lead sponsor	Peking University People's Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	25 May 2023
Primary completion	3 August 2024
Estimated completion	3 August 2024
Sites	2 locations across China

Drugs / interventions tested

• LILRB4 STAR-T cells

Conditions studied

• Relapsed/Refractory Acute Myeloid Leukemia and Chronic Granulocytic-Mononocytic Leukemia — all drugs for Relapsed/Refractory Acute Myeloid Leukemia and Chronic Granulocytic-Mononocytic Leukemia →

Sponsor

Peking University People's Hospital

Who can join

Adults 18 to 60, any sex, with Relapsed/Refractory Acute Myeloid Leukemia and Chronic Granulocytic-Mononocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Human leukocyte immunoglobulin-like receptors in health and disease.
   Redondo-García S, Barritt C, Papagregoriou C, Yeboah M, et al · · 2023 · cited 34× · PMID 38022598 · DOI 10.3389/fimmu.2023.1282874
2. The LILRB family in hematologic malignancies: prognostic associations, mechanistic considerations, and therapeutic implications.
   Hodges A, Dubuque R, Chen SH, Pan PY. · · 2024 · cited 9× · PMID 39696628 · DOI 10.1186/s40364-024-00705-7
3. Transitioning from native to synthetic receptors: broadening T-cell engineering and beyond.
   Yu L, Liu Y, Lin X. · · 2025 · cited 5× · PMID 40481182 · DOI 10.1038/s41423-025-01304-8
4. Leukocyte immunoglobulin-like receptor B4 (LILRB4) in acute myeloid leukemia: From prognostic biomarker to immunotherapeutic target.
   Li M, Zhao X. · · 2024 · cited 5× · PMID 38973293 · DOI 10.1097/cm9.0000000000003195
5. Inhibitory leukocyte immunoglobulin-like receptors, subfamily B (LILRBs) in human diseases: structure, roles, mechanisms, and clinical applications.
   Zhang Y, Xu Y, Wu Q, Fu X, et al · · 2025 · cited 1× · PMID 40860159 · DOI 10.7150/thno.116951
6. Dual epitope anti-LILRB4 synthetic T-cell receptor and antigen receptor (STAR)-T-cell therapy for relapsed/refractory acute myeloid leukemia.
   Lv M, Zheng H, Pei X, Lei L, et al · · 2026 · PMID 42225613 · DOI 10.1038/s41392-026-02765-7
7. The TCR and LCK: foundations for T-cell activation and therapeutic innovation.
   Woessner NM, Uleri V, Stepanek O, Minguet S. · · 2025 · PMID 41601693 · DOI 10.3389/fimmu.2025.1737013
8. Marrow Microenvironmental Pathobiology and Therapeutic Opportunities for <i>TP53</i>-Mutated Myelodysplastic Syndrome/Acute Myeloid Leukemia.
   Hunter CJ, Im AP, Shallis RM. · · 2026 · PMID 41595195 · DOI 10.3390/cancers18020275