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

Description

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

Relapsed or Resistant Acute Leukaemias

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Relapsed or Resistant Acute Leukaemias
Intervention / Treatment

-

Contacts and Locations

Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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

Ages Eligible for Study

18 Years to 120 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lin BioScience, Inc,

Study Record Dates

2025-12-15