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

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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorLTZ Therapeutics, Inc.

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

Sponsors and collaborators

LTZ Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov