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RECRUITING
NCT05756322
PHASE1/PHASE2

The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias

Sponsor: Lin BioScience, Inc

View on ClinicalTrials.gov

Summary

The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages. The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.

Official title: A Phase 1/2, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-07-20

Completion Date

2026-12-31

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

LBS-007

Open Label.

Locations (17)

Moffitt Cancer Center

Tampa, Florida, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

The University of Kansas Hospital

Fairway, Kansas, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wollongong Private Hospital

Wollongong, New South Wales, Australia

Pindara Private Hospital

Benowa, Queensland, Australia

The Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Hollywood Private Hospital

Nedlands, Washington, Australia

Q Medical Conselling

Perth, Washington, Australia

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Jining No.1 People's Hospital

Jining, Shandong, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan