NCT07121946PHASE1Recruiting
This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
LTZ Therapeutics, Inc.
Start Date
1/29/2026
Completion Date
2/1/2028
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
Detailed Description
LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
BIOLOGICAL
LTZ-301
BIOLOGICAL
LTZ-301
BIOLOGICAL
LTZ-301
Conditions
Non-Hodgkin Lymphoma Refractory/ RelapsedDLBCL - Diffuse Large B Cell LymphomaMantle Cell Lymphoma (MCL)Follicular Lymphoma ( FL)Marginal Zone Lymphoma (MZL)
Locations
City of Hope
Duarte, California 91010
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Memorial Sloan Kettering Cancer Center - Bergen
New York, New York 10065
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States