A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
LTZ Therapeutics, Inc.
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
Description
LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Relapsed or refractory to at least 2 prior systemic treatment regimens * At least 1 bi-dimensionally measurable lesion (≥ 1.5 cm) in longest dimension * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate bone marrow, cardiac, pulmonary, renal, and hepatic function Exclusion Criteria: * CLL, or Richters transformation * Prior solid organ transplant * Prior allogeneic stem cell transplant * ASCT within 100 days prior to the first LTZ-301 administration * Prior CAR-T within 60 days prior to the first LTZ-301 administration *…
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
Locations (5)
- City of HopeDuarte, California
- Washington University School of MedicineSt Louis, Missouri
- Roswell Park Cancer InstituteBuffalo, New York
- Tennessee OncologyNashville, Tennessee
- Fred Hutchinson Cancer CenterSeattle, Washington