This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
NCT ID: NCT07121946
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
42 participants
INTERVENTIONAL
2026-01-31
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Subjects in this arm will participate in one (1) of eight (8) escalating defined dose level cohorts. Subjects will receive up to 54 weeks of LTZ-301 intravenously.
LTZ-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.
Backfill Expansion
Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.
LTZ-301
LTZ-301will be dosed IV, as above
Expansion
A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type.
LTZ-301
LTZ-301will be dosed IV, as above
Interventions
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LTZ-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.
LTZ-301
LTZ-301will be dosed IV, as above
LTZ-301
LTZ-301will be dosed IV, as above
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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LTZ Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Tennessee Oncology
Nashville, Tennessee, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LTZ-301-001
Identifier Type: -
Identifier Source: org_study_id
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