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

Recruiting now · Phase 1

Conditions studied: Non-Hodgkin Lymphoma Refractory/ Relapsed, DLBCL - Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma (MCL), Follicular Lymphoma ( FL), Marginal Zone Lymphoma (MZL)

In brief

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

Key facts

Study ID

NCT07121946

Run by

LTZ Therapeutics, Inc.

People needed

42

Starts

2026-01-29

Expected to finish

2028-02-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center - Bergen — New York, New York, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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