RecruitingPhase 1NCT07121946

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


Sponsor

LTZ Therapeutics, Inc.

Enrollment

42 participants

Start Date

Jan 29, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase (Phase 1) safety study testing a new drug called LTZ-301 in people with a type of blood cancer called Non-Hodgkin Lymphoma that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 years or older - You have Non-Hodgkin Lymphoma that has returned or stopped responding to at least 2 prior treatments - You have at least one measurable tumor (1.5 cm or larger) - You are in relatively good physical condition (able to carry out daily activities) - Your heart, lungs, liver, kidneys, and bone marrow are functioning adequately **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal fluid - You have had certain other cancer treatments recently - You have uncontrolled infections or serious other illnesses - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLTZ-301

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.

BIOLOGICALLTZ-301

LTZ-301will be dosed IV, as above

BIOLOGICALLTZ-301

LTZ-301will be dosed IV, as above


Locations(5)

City of Hope

Duarte, California, United States

Washington University School of Medicine

St Louis, Missouri, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Tennessee Oncology

Nashville, Tennessee, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07121946


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