Health Trials

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

CLL, or Richters transformation

Prior solid organ transplant

Prior allogeneic stem cell transplant

ASCT within 100 days prior to the first LTZ-301 administration

Trial design

Treatments tested in this trial

  • LTZ-301
  • LTZ-301
  • LTZ-301

Treatment groups

42 Participants
are divided into 3 treatment groups

Locations

5
City of Hope91010, DuarteCalifornia, United States
Washington University School of Medicine63110, St LouisMissouri, United States
Roswell Park Cancer Institute14263, BuffaloNew York, United States
Tennessee Oncology37203, NashvilleTennessee, United States

Sponsors and collaborators

LTZ Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov