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

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

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Key information

Conditions

Non-Hodgkin Lymphoma Refractory/ Relapsed DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Follicular Lymphoma ( FL) Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma (MCL) Marginal Zone Lymphoma (MZL) Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LTZ-301

Biological

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.

Primary outcomes

Safety and Tolerability

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sherry Unabia

CONTACT

[email protected]

669-207-0084

Sponsors and collaborators

Lead sponsor

LTZ Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Aug 14, 2025
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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