Back to Trials
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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

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