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New hope for hard-to-treat lymphoma: first human trial of LTZ-301 begins

NCT ID NCT07121946

Disease control Sponsor: LTZ Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This early-phase trial tests a new drug called LTZ-301 in 42 adults with certain types of non-Hodgkin lymphoma that have not responded to at least two prior treatments. The main goal is to check the drug's safety and find the right dose. Researchers will also look for signs that the drug is shrinking tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

B-cell non-Hodgkin lymphoma diffuse large B-cell lymphoma follicular lymphoma interdigitating dendritic cell sarcoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DLBCL - diffuse large B cell lymphoma Follicular lymphoma (FL) Mantle cell lymphoma (MCL) Marginal zone lymphoma (MZL) Non-Hodgkin lymphoma refractory/ relapsed

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Memorial Sloan Kettering Cancer Center - Bergen

    RECRUITING

    New York, New York, 10065, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.