Study on the Safety and Tolerability of LBS-007 in Patients with Relapsed or Resistant Acute Leukemias
Sponsor: Lin BioScience, Inc
ClinicalTrials ID:NCT05756322
This clinical trial is testing a new drug, LBS-007, to see if it is safe and well-tolerated in patients with acute leukemias that have returned or are not responding to treatment. The study also aims to understand how the drug works in the body and its effectiveness.
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Program Overview
Acute leukemias are fast-growing blood cancers, with the most common types being acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). AML is a severe form of leukemia in adults, while ALL involves the growth of cancerous blood cells. This study is focused on testing the safety and tolerability of a new drug, LBS-007, in patients whose leukemia has come back or is resistant to treatment. Researchers will also look at how effective the drug is and how it behaves in the body. Additionally, they will explore changes in certain biological markers in response to the treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older.
- Diagnosed with relapsed or resistant acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL).
- Not eligible for standard treatments that are expected to lead to long-term remission or cure, or have no other known beneficial treatment options.
- In good general health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Currently receiving chemotherapy, radiation, or immunotherapy.
- Participating in another clinical trial or taking investigational drugs within 30 days before screening.
- Have acute promyelocytic leukemia or leukemia that has spread to the central nervous system.
- Have had another active cancer within the last 2 years, except for certain skin cancers or previously treated cancers.
- Have mental health issues or a history of psychiatric conditions.
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