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)

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
University of California Irvine Medical Center
RECRUITING
Orange
Florida
Baptist Health South Florida-Miami Cancer Institute
RECRUITING
Miami
Kentucky
Norton Healthcare-Norton Cancer Institute
RECRUITING
Louisville
Massachusetts
Mass. General Hospital-Harvard
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Virginia
Virginia Commonwealth University Medical Center
RECRUITING
Richmond
Contact Information
Primary
Chris Korth
clinicaltrials@puretechhealth.com
617-982-2550
Backup
Aleksandra Filipovic, MD, PhD.
clinicaltrials@puretechhealth.com
617-982-2550
Time Frame
Start Date: 2022-12-12
Estimated Completion Date: 2026-03
Participants
Target number of participants: 90
Treatments
Experimental: 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.
Experimental: 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.
Sponsors
Leads: PureTech

This content was sourced from clinicaltrials.gov

Similar Clinical Trials