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)
NCT ID: NCT05829226
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2022-12-12
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Single agent dose escalation
LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week.
LYT-200
monoclonal antibody (mAb), targeting galectin-9 protein
Combination agent dose escalation
LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week, in combination with oral venetoclax Day 1, 100 mg, Day 2, 200mg, Day 3-28, 400 mg and/or azacitidine, 75 mg/m2 subcutaneously given for 7 days per cycle or decitabine 20 mg/m2 IV for 5 days per cycle.
LYT-200
monoclonal antibody (mAb), targeting galectin-9 protein
Venetoclax
Bcl-2 inhibitor
Azacitidine
Hypomethylating agent
Decitabine
Hypomethylating agent
Interventions
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LYT-200
monoclonal antibody (mAb), targeting galectin-9 protein
Venetoclax
Bcl-2 inhibitor
Azacitidine
Hypomethylating agent
Decitabine
Hypomethylating agent
Eligibility Criteria
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Inclusion Criteria
* 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.
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Patient must meet the following criteria as indicated on the clinical laboratory tests:
oWhite blood cell (WBC) count at the time of the first dose of \< 25,000/uL. oAspartate aminotransferase or alanine aminotransferase ≤ 3 × upper limit of normal (ULN; ≤ 5.0× ULN if considered to be due to leukemic involvement). oTotal bilirubin ≤ 2 × ULN (≤ 3 × ULN if considered to be due to leukemic involvement orGilbert's syndrome). oCreatinine clearance of ≥ 60 mL/min.
Exclusion Criteria
* Patient has active malignant tumors other than AML/MDS
* Patient has had HSCT and meets any of the following: has undergone HSCT within the 6- month period prior to the first study dose; has ≥ Grade 2 persistent non-hematological toxicity related to the transplant donor lymphocytes infusion.
* Patient has active graft versus host disease (GVHD) and patients receiving immunosuppressive treatment for GVHD.
* Patient with symptomatic central nervous system (CNS) involvement of leukemia or other CNS diseases related to underlying and secondary effects of malignancy
* Patient has had major surgery within 4 weeks prior to the first study dose.
* Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.
* Patient has any condition which, in the Investigator's opinion, makes the patient unsuitable for study participation.
18 Years
ALL
No
Sponsors
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PureTech
INDUSTRY
Responsible Party
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Principal Investigators
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Aleksandra Filipovic, MD, PhD.
Role: STUDY_DIRECTOR
PureTech Health
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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LYT-200-2022-02
Identifier Type: -
Identifier Source: org_study_id
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