RecruitingPhase 1NCT05829226

A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

A Phase 1 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)


Sponsor

PureTech

Enrollment

90 participants

Start Date

Dec 12, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase 1 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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called LYT-200 — which works by blocking a pathway that helps cancer cells hide from the immune system — in people with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with AML or high-risk MDS that has relapsed or is refractory (not responding) to at least one prior treatment - No standard treatment is available or you have declined available standard of care - Your ECOG performance status is 0, 1, or 2 (you are reasonably active) - Your white blood cell count is below 25,000 at the time of starting treatment - Your liver and kidney function meets the study thresholds **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a specific subtype of AML) - You have another active cancer besides AML or MDS - You had a bone marrow transplant from a donor within the past 6 months, or you still have active graft-versus-host disease - You have significant active central nervous system (brain) involvement from your leukemia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLYT-200

monoclonal antibody (mAb), targeting galectin-9 protein

DRUGVenetoclax

Bcl-2 inhibitor

DRUGAzacitidine

Hypomethylating agent

DRUGDecitabine

Hypomethylating agent


Locations(9)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California Irvine Medical Center

Orange, California, United States

Baptist Health South Florida-Miami Cancer Institute

Miami, Florida, United States

Norton Healthcare-Norton Cancer Institute

Louisville, Kentucky, United States

Mass. General Hospital-Harvard

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05829226


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