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This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 * Current central nervous system (CNS) lymphoma * 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
About the study
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
What is being tested
- LTZ-301 (biological)
- LTZ-301 (biological)
- LTZ-301 (biological)
Sponsor: LTZ Therapeutics, Inc. · Participants: 42 · Started: Jan 29, 2026
Contact the study team
- Sherry Unabia · Phone: 669-207-0084
Official record on ClinicalTrials.gov — NCT07121946
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.