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
LTZ Therapeutics, Inc.
42 participants
Jan 29, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria11
- 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
Interventions
LTZ-301 will be dosed IV, in initial 28 day cycles. First cycle dosing is every week. Second through fifth cycles are dosed every 2 weeks. Sixth cycle and beyond are 21 day cycles, and are dosed once every 3 weeks.
LTZ-301will be dosed IV, as above
LTZ-301will be dosed IV, as above
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07121946