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

Part of paid clinical trials in Duarte, California.

Sponsor
LTZ Therapeutics, Inc.
Study ID
NCT07121946
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • LTZ-301 — BIOLOGICAL
    LTZ-301will be dosed IV, as above
  • LTZ-301 — BIOLOGICAL
    LTZ-301will be dosed IV, as above

Study Details

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

Key Dates

First listed
Aug 14, 2025
Start date
Jan 29, 2026
Status verified
Jan 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Safety and Tolerability [ Time Frame: Up to 54 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Elizabeth Budde, MD
[email protected]
626-218-2405
Washington University School of MedicineSt LouisMissouri63110
Anne Fischer
[email protected]
314-362-3021
Roswell Park Cancer InstituteBuffaloNew York14263
Francisco Hernandez, MD
[email protected]
716-845-2300
Tennessee OncologyNashvilleTennessee37203
Michael Byrne, DO
[email protected]
888-550-2835
Fred Hutchinson Cancer CenterSeattleWashington98109
Ajay Gopal, MD
[email protected]
206-606-2037

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAWashington University School of Medicine· St Louis, MORoswell Park Cancer Institute· Buffalo, NYTennessee Oncology· Nashville, TNFred Hutchinson Cancer Center· Seattle, WA

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