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PhI of LYT-200 in Pts w/ R/R AML or w/ R/R, High/Very High Risk MDS

UCI Specialty Area: Cancer
Principal Investigator: Deepa Jeyakumar
Official Title: A Phase I, Open-Label, Multi-Center Study of the Safety, Pharmacokinetics (PK), and Anti-Tumor Activity of LYT-200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/Refractory, High-Risk Myelodysplastic Syndrome (MDS)
A Study On:
Myeloid and Monocytic Leukemia
Other Hematopoietic

Study Description

We are enrolling cancer of the blood and bone marrow patients. In this study, we are looking at a new investigational drug called LYT-200 that is intended to inhibit (hinder) galectin-9. Galectin-9 is a protein which suppresses immune functionand disables immune-mediated attack on the cancer cells through multiple pathways. At present, there are no approved therapies targeting galectin-9 for any disease. Early studies conducted in

animals suggest LYT-200 might be a good treatment for patients with blood and bone marrow

cancer.

This study is among the first research studies of LYT-200 in people and its main purpose is to

test its safety and tolerability in patients suffering from two types of blood and bone marrow

cancer: acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). In this study we

shall also examine how the drug is changed by and removed from the body and will look for

signs that the drug may be effective against AML or MDS. LYT-200 will be tested at several

different doses.

Eligibility

You have had at least one line of therapy for AML or MDS and your cancer relapsed or

was refractory (resistant) to treatment and there are no standard treatment options

available that are known to be effective to treat your cancer or you have refused to

receive treatment with standard of care treatments.

You are up and about and are able to visit the study center frequently.

You have satisfactory blood test results and medical examination.

You are able to conceive a child, you are not pregnant and you agree to use two forms

of birth control (one of which must be a barrier method) starting at screening and for

90 days after receiving the final study drug administration.

You and your partner who could conceive a child agree to use two forms of birth

control (one of which must be a barrier method) starting at screening.

You have agreed not to donate your reproductive material (ova) or breastfeed for the

period of the study and for 90 days after receiving the final study drug administration.

You have not taken any anticancer medications in at least the last 2 weeks or in the

amount of time needed for the previous anticancer medication to clear from your body

(otherwise known as half-life of the drug), which can be shorter than 2 weeks, and your

doctor will know.

You have not had major surgery or radiation therapy within 4 weeks prior to the first

study dose.

You have not received any live vaccine within 30 days prior to the first study dose.

A female nurse attentively holds a tablet, ready to assist with patient care and medical information.

Interested in Participating in this Trial?

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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