This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
Trial Parameters
Brief 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
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