Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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