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

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

LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis

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