Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07121946

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

Led by LTZ Therapeutics, Inc. · Updated on 2026-02-10

42

Participants Needed

5

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Relapsed or refractory to at least 2 prior systemic treatment regimens
  • At least 1 measurable lesion 1.5 cm or larger in longest dimension
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, cardiac, pulmonary, renal, and hepatic function
Not Eligible

You will not qualify if you...

  • Chronic lymphocytic leukemia (CLL) or Richters transformation
  • Prior solid organ transplant
  • Prior allogeneic stem cell transplant
  • Autologous stem cell transplant (ASCT) within 100 days before first LTZ-301 dose
  • Prior CAR-T therapy within 60 days before first LTZ-301 dose
  • Current central nervous system lymphoma
  • Known HIV infection
  • Active autoimmune disease
  • History of significant cardiovascular disease
  • Symptomatic deep vein thrombosis within 3 months before enrollment
  • History of other malignancy within 3 years before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

City of Hope

Duarte, California, United States, 91010

Actively Recruiting

2

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

3

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

4

Tennessee Oncology

Nashville, Tennessee, United States, 37203

Actively Recruiting

5

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

S

Sherry Unabia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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