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

Purpose

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

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
Experimental
Backfill Expansion 		Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.
  • Biological: LTZ-301
    LTZ-301will be dosed IV, as above
Experimental
Expansion 		A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type.
  • Biological: LTZ-301
    LTZ-301will be dosed IV, as above
  • Biological: LTZ-301
    LTZ-301will be dosed IV, as above

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Anne Fischer
314-362-3021
afischer@wustl.edu

More Details

NCT ID
NCT07121946
Status
Recruiting
Sponsor
LTZ Therapeutics, Inc.

Study Contact

Sherry Unabia
669-207-0084
sherry.unabia@ltztherapeutics.com

Detailed Description

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