Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 120Years
All Genders
NCT05756322

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

Led by Lin BioScience, Inc · Updated on 2026-03-27

90

Participants Needed

17

Research Sites

180 weeks

Total Duration

On this page

Sponsors

L

Lin BioScience, Inc

Lead Sponsor

L

Lin BioScience Pty Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

2

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States, 60611

Not Yet Recruiting

3

The University of Kansas Hospital

Fairway, Kansas, United States, 66205

Actively Recruiting

4

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21287

Actively Recruiting

5

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

6

Wollongong Private Hospital

Wollongong, New South Wales, Australia

Completed

7

Pindara Private Hospital

Benowa, Queensland, Australia

Completed

8

The Royal Adelaide Hospital

Adelaide, South Australia, Australia

Actively Recruiting

9

The Alfred Hospital

Melbourne, Victoria, Australia

Active, Not Recruiting

10

Hollywood Private Hospital

Nedlands, Washington, Australia

Withdrawn

11

Q Medical Conselling

Perth, Washington, Australia, 6009

Withdrawn

12

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China, 453100

Actively Recruiting

13

Jining No.1 People's Hospital

Jining, Shandong, China, 272011

Actively Recruiting

14

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

Tianjin, China, 300020

Actively Recruiting

15

China Medical University Hospital

Taichung, Taiwan

Not Yet Recruiting

16

National Cheng Kung University Hospital

Tainan, Taiwan

Not Yet Recruiting

17

National Taiwan University Hospital

Taipei, Taiwan

Not Yet Recruiting

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Research Team

L

Lin BioScience Clinical Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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