A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• 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
Locations
United States
California
City of Hope
RECRUITING
Duarte
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Tennessee
Tennessee Oncology
RECRUITING
Nashville
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Contact Information
Primary
Sherry Unabia
sherry.unabia@ltztherapeutics.com
669-207-0084
Time Frame
Start Date: 2026-01-29
Estimated Completion Date: 2028-02
Participants
Target number of participants: 42
Treatments
Experimental: 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.
Experimental: Backfill Expansion
Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.
Experimental: Expansion
A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type.
Related Therapeutic Areas
Sponsors
Leads: LTZ Therapeutics, Inc.