Phase 1 Study of LTZ-301 for Non-Hodgkin Lymphoma

This study is testing a new treatment called LTZ-301 for adults with non-Hodgkin lymphoma that has returned or not responded to at least two previous treatments. This is a first-in-human, Phase 1 study, meaning it's the first time LTZ-301 is being given to people. Researchers want to see how safe LTZ-301 is and how well your body tolerates it. They will also look at how the drug moves through your body and if it shows any signs of fighting cancer. LTZ-301 is a bispecific antibody that targets cancer cells. The study plans to enroll 42 participants. The current status of this study is unclear.

Study design
This is a Phase 1, multicenter, open-label study, meaning you and your doctors will know you are receiving LTZ-301. It plans to enroll 42 adult participants.
What's involved
You would receive LTZ-301 intravenously (through a vein) in cycles. Dosing frequency changes over the first few cycles, starting weekly and then moving to every two or three weeks.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be measured for up to 54 weeks.

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NCT07121946

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
LTZ Therapeutics, Inc.
~42 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:LTZ-301

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over Up to 54 weeks
Non-Hodgkin Lymphoma Refractory/ Relapsed
DLBCL - Diffuse Large B Cell Lymphoma
Mantle Cell Lymphoma (MCL)
Follicular Lymphoma ( FL)
Marginal Zone Lymphoma (MZL)
6 sites across 5 states
New York2
California1
Missouri1
Tennessee1
Washington1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Safety and TolerabilityUp to 54 weeks

    To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria.