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

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 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

Conditions6

Locations5 sites

Browse More Trials