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The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
Sponsor: Lin BioScience, Inc
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
Conditions
Interventions
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