What is the Purpose of this Study?
The purpose of this study is to evaluate the safety and tolerability of an investigational drug called LYT 200 in two types of blood and bone marrow cancer: acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The study focuses on individuals who have had at least one line of therapy for AML or MDS and whose cancer has relapsed or was refractory (resistant) to treatment. Researchers will also examine how LYT-200 is changed by and removed from the body, as well as evaluate its preliminary effectiveness and recommended dose. LYT-200 is intended to inhibit (hinder) galectin 9, which is a protein that suppresses immune function and disables immune-mediated attack on the cancer cells. Participants will receive 1 of 5 different doses of LYT-200 in this study.
Eligibility
- * Patients ≥ 18 years of age at the time of obtaining informed consent.
- * Patients with morphologically documented primary or secondary AML by the World Health Organization(WHO) criteria, whose disease is relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant and for whom no standard therapy that may provide clinical benefit is available or for patients who decline available standard of care.
- * Patients with a documented diagnosis of high-risk myelodysplastic syndrome (MDS), whose disease is relapsed/refractory, post at least one line of treatment based on the revised International Prognostic Scoring System (IPSS-R) and for whom no standard therapy that may provide clinical benefit is available
- * Patients are able and willing to comply with study procedures as per protocol, including bone marrowbiopsies.
Where can I participate?
- Cedars-Sinai Cancer at Beverly Hills (THO)
- Cedars-Sinai Cancer at SOCC
More about this Clinical Trial
What is the full name of this clinical trial?
LYT-200-2022-02: A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics , and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/refractory Acute Myeloid Leukemia , or with Relapsed/refractory, High-risk Myelodysplastic Syndrome