NCT07121946

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

A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: LTZ Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis

Conditions

• Non-Hodgkin Lymphoma Refractory/ Relapsed
• DLBCL - Diffuse Large B Cell Lymphoma
• Mantle Cell Lymphoma (MCL)
• Follicular Lymphoma ( FL)
• Marginal Zone Lymphoma (MZL)

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	LTZ-301	LTZ-301will be dosed IV, as above
BIOLOGICAL	LTZ-301	LTZ-301will be dosed IV, as above

Timeline

• Start date: 2026-01-29
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-08-14
• Last updated: 2026-02-10

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study