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

Not Applicable

Not yet recruiting

• Conditions: Non-Hodgkin Lymphoma Refractory/ Relapsed; DLBCL - Diffuse Large B Cell Lymphoma; Mantle Cell Lymphoma (MCL); Follicular Lymphoma ( FL); Marginal Zone Lymphoma (MZL)
• Interventions: Biological: LTZ-301

• Registration Number: NCT07121946
• Lead Sponsor: LTZ Therapeutics, Inc.

Brief 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

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-01
• Primary Completion: 2028-02
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 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

Exclusion Criteria

• CLL, or Richters transformation
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	LTZ-301	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.
Backfill Expansion	LTZ-301	Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.
Expansion	LTZ-301	A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	Up to 54 weeks	To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria.

Trial Locations

Locations (1)

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States