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

Launched by LTZ THERAPEUTICS, INC. · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called LTZ-301 to see if it is safe and well-tolerated in adults with certain types of non-Hodgkin lymphoma (a kind of blood cancer) that has come back or has not responded to previous treatments. The study is an early-phase trial, which means it’s mainly focused on finding out how the drug behaves in the body and whether it shows any signs of helping to shrink tumors.

Adults aged 18 and older who have tried at least two different treatments for their lymphoma but still have active disease may be eligible to join. Participants need to have measurable tumors and be in relatively good health, with no serious heart, lung, or other organ problems. People with certain conditions, like recent stem cell transplants, active infections like HIV, or other recent cancers, would not be able to join. If you take part, you can expect to receive LTZ-301 as a single treatment while doctors closely monitor your health and any side effects. This study is not yet open for enrollment, but it offers hope for new treatment options in patients whose lymphoma has been difficult to treat.

Gender

ALL

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