Actively Recruiting
A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Led by LTZ Therapeutics, Inc. · Updated on 2026-02-10
42
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of LTZ-301 in adults with relapsed or refractory B-cell non-Hodgkin lymphoma. LTZ-301 is a bispecific antibody designed to engage myeloid cells and target B-cells through CD79B to trigger phagocytosis. This phase 1, open-label, multicenter study aims to understand how this treatment behaves and its safety profile in this patient group. Participants will receive LTZ-301 intravenously in one of eight escalating dose cohorts over up to 54 weeks. The dosing schedule starts with weekly infusions during the first 28-day cycle, followed by infusions every two weeks from the second to the fifth cycle. From the sixth cycle onward, infusions occur every three weeks in 21-day cycles. Some participants may receive doses declared safe earlier to further assess safety and activity, and additional subjects may be enrolled at selected dose levels to explore effects in specific lymphoma types. Throughout the study, participants will be monitored closely for safety and tolerability for up to 54 weeks. Researchers will assess the treatment's effects on the lymphoma, collecting data on how the body processes the drug and its biological impact. Participants will undergo evaluations including scans of measurable lesions, and assessments of bone marrow, heart, lung, kidney, and liver functions. The study tracks adverse events and overall health to understand the treatment's profile in this patient group.
CONDITIONS
Brief 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 of 1.5 cm or larger in longest dimension
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate bone marrow, cardiac, pulmonary, renal, and hepatic function
You will not qualify if you...
- Chronic lymphocytic leukemia or Richter's transformation
- Prior solid organ transplant
- Prior allogeneic stem cell transplant
- Autologous stem cell transplant 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 seropositivity
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 54 weeks
Participants receive LTZ-301 intravenously in cycles with varying dosing schedules: weekly dosing during the first 28-day cycle, every 2 weeks for cycles two through five, and every 3 weeks for the sixth cycle and beyond. Treatment may last up to 54 weeks depending on individual response and tolerance.
Weekly visits during cycle 1, biweekly visits during cycles 2 to 5, and visits every 3 weeks from cycle 6 onward
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
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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