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RecruitingInterventionalPhase 1

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

NCT ID: NCT07121946Sponsor: LTZ Therapeutics, Inc.Last updated: 2026-02-10

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

Arms & interventions

  • BiologicalLTZ-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.

  • BiologicalLTZ-301

    LTZ-301will be dosed IV, as above

  • BiologicalLTZ-301

    LTZ-301will be dosed IV, as above

Outcome measures

Primary

  • Safety and Tolerability

    To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria.

    Time frame: Up to 54 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (5)

City of Hope

Duarte, California, 91010

Recruiting
Elizabeth Budde, MD · Contact

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting
Anne Fischer · Contact

Roswell Park Cancer Institute

Buffalo, New York, 14263

Recruiting
Francisco Hernandez, MD · Contact

Tennessee Oncology

Nashville, Tennessee, 37203

Recruiting
Michael Byrne, DO · Contact

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Ajay Gopal, MD · Contact