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

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed or Resistant Acute Leukaemias

In brief

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.

Key facts

Study ID

NCT05756322

Run by

Lin BioScience, Inc

People needed

90

Starts

2023-07-20

Expected to finish

2026-12-31

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects greater than 18 years old, inclusive.
• Pathologically confirmed diagnoses of Relapsed or resistant AML or ALL.
• Patients who are ineligible for standard therapies that are anticipated to result in durable remission or cure, or who have no known therapy options of documented benefit.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

You may not qualify if…

• Concomitant chemotherapy, radiation therapy, or immunotherapy.
• Receiving any other investigational agents concurrently or within 30 days prior to screening.
• Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement.
• History of another active malignancy with 2 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively.
• Patient with mental deficits and/or psychiatric history that precludes them from giving informed consent or from following protocol.

Where it is running

• The University of Kansas Hospital — Fairway, Kansas, United States (enrolling)
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (enrolling)
• Jining No.1 People's Hospital — Jining, Shandong, China (enrolling)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, China (enrolling)
• The Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• National Cheng Kung University Hospital — Tainan, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• Wollongong Private Hospital — Wollongong, New South Wales, Australia
• Pindara Private Hospital — Benowa, Queensland, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Hollywood Private Hospital — Nedlands, Washington, Australia
• Q Medical Conselling — Perth, Washington, Australia
• China Medical University Hospital — Taichung, Taiwan

Full record on ClinicalTrials.gov

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