A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Summary
This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor activity of LTZ-301 administered as a single agent in adult subjects with relapsed or refractory B-cell non-Hodgkin lymphoma
Detailed description
LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis
Arms & interventions
- BiologicalLTZ-301
LTZ-301 will be dosed IV, in initial 28 day cycles. First cycle dosing is every week. Second through fifth cycles are dosed every 2 weeks. Sixth cycle and beyond are 21 day cycles, and are dosed once every 3 weeks.
- BiologicalLTZ-301
LTZ-301will be dosed IV, as above
- BiologicalLTZ-301
LTZ-301will be dosed IV, as above
Outcome measures
Primary
Safety and Tolerability
To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria.
Time frame: Up to 54 weeks
Eligibility criteria
Study locations (5)
City of Hope
Duarte, California, 91010
Washington University School of Medicine
St Louis, Missouri, 63110
Roswell Park Cancer Institute
Buffalo, New York, 14263
Tennessee Oncology
Nashville, Tennessee, 37203
Fred Hutchinson Cancer Center
Seattle, Washington, 98109