Tests LTZ-301 safety in adults with relapsed non-Hodgkin lymphoma
Tests LTZ-301, a new treatment, in adults whose B-cell lymphoma returned or did not respond.
Plain-language title generated from the registry record
Registry title: This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
Key facts
- Where
- Buffalo, Duarte, Nashville, New York, Seattle, and St Louis, United StatesSee the 6 sites
- Phase
- Phase 1
Where in United States
- Roswell Park Cancer InstituteBuffalo, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- Tennessee OncologyNashville, United StatesTaking people
- Memorial Sloan Kettering Cancer Center - BergenNew York, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- LTZ Therapeutics, Inc.
- Trial code
- NCT07121946
- Record updated
- 24 July 2026
- Original description
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 lymphomaRead full original descriptionShow less
A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
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
Inclusion: 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: 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; Known history of human immunodeficiency virus (HIV) seropositivity; Active autoimmune disease; History of clinically significant cardiovascular disease; symptomatic deep vein thrombosis (DVT) within 3 months of enrollment; History of other malignancy within 3 years prior to screening; CLL, or Richters transformation; Current central nervous system (CNS) lymphoma.