LBS-007 for Relapsed or Resistant Acute Leukemias

This study is testing a drug called LBS-007 for people with acute leukemias (a type of blood cancer) that have come back (relapsed) or are not responding to treatment (resistant). The most common types of acute leukemia are acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). This study is open to adults aged 18 and older who have relapsed or resistant ALL or AML and who are not eligible for standard treatments or have no other known treatment options. The main goals are to understand how safe LBS-007 is, what side effects it might cause, and to find the best dose. The study will also look at how well LBS-007 works. The study is currently recruiting about 90 participants.

Study design
This is an interventional study testing the drug LBS-007. It is an open-label study, meaning both you and your doctors will know you are receiving LBS-007.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored from the start of the study through 28 days after your last treatment cycle, for up to 12 months.

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NCT05756322

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lin BioScience, Inc
~90 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:LBS-007

At a glance

Recruiting sites
8 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
Measured over From baseline through 28 days after end of last treatment cycle (up to 12 months)
+1 more outcome measured
Relapsed or Resistant Acute Leukaemias
17 sites across 14 states
Taiwan3
Washington2
Florida1
Illinois1
Kansas1
Maryland1
North Carolina1
New South Wales1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.From baseline through 28 days after end of last treatment cycle (up to 12 months)
  • Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population.From baseline through 28 days after end of last treatment cycle (up to 12 months)