RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07121946

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Relapsed or refractory to at least 2 prior systemic treatment regimens
  3. * At least 1 bi-dimensionally measurable lesion (≥ 1.5 cm) in longest dimension
  4. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  5. * Adequate bone marrow, cardiac, pulmonary, renal, and hepatic function
  1. * CLL, or Richters transformation
  2. * Prior solid organ transplant
  3. * Prior allogeneic stem cell transplant
  4. * ASCT within 100 days prior to the first LTZ-301 administration
  5. * Prior CAR-T within 60 days prior to the first LTZ-301 administration
  6. * Current central nervous system (CNS) lymphoma
  7. * Known history of human immunodeficiency virus (HIV) seropositivity
  8. * Active autoimmune disease
  9. * History of clinically significant cardiovascular disease
  10. * symptomatic deep vein thrombosis (DVT) within 3 months of enrollment
  11. * History of other malignancy within 3 years prior to screening

Contacts and Locations

Study Locations (Sites)

Tennessee Oncology
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: LTZ Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2028-02

Study Record Updates

Study Start Date2025-09
Study Completion Date2028-02

Terms related to this study

Additional Relevant MeSH Terms

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