RECRUITING

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

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

Conditions

Non-Hodgkin Lymphoma Refractory/ RelapsedDLBCL - Diffuse Large B Cell LymphomaMantle Cell Lymphoma (MCL)Follicular Lymphoma ( FL)Marginal Zone Lymphoma (MZL)
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Related Conditions:

Non-Hodgkin Lymphoma Refractory/ RelapsedDLBCL - Diffuse Large B Cell LymphomaMantle Cell Lymphoma (MCL)Follicular Lymphoma ( FL)Marginal Zone Lymphoma (MZL)

Study Overview

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Study Details

Study overview

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

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

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

Condition
Non-Hodgkin Lymphoma Refractory/ Relapsed
Intervention / Treatment

-

Contacts and Locations

Nashville

Tennessee Oncology, Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

LTZ Therapeutics, Inc.,

Study Record Dates

2028-02