LTZ-301 for Non-Hodgkin's Lymphoma

Recruiting at 2 trial locations

Overseen By Sherry Unabia

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: LTZ Therapeutics, Inc.

Disqualifiers: CLL, CNS lymphoma, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LTZ-301, a potential drug for individuals with B-cell non-Hodgkin lymphoma that has returned or hasn't responded to at least two treatments. The trial aims to determine the safety of LTZ-301 and its effectiveness against tumors. Participants will join different groups to try various doses and identify the most effective one. This trial may suit those with non-Hodgkin lymphoma who have measurable tumors and have not succeeded with other treatments. As a Phase 1 trial, participants will be among the first to receive LTZ-301, aiding researchers in understanding how this new treatment works in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LTZ-301 is likely to be safe for humans?

Research shows that LTZ-301 is being tested for safety in people with non-Hodgkin's lymphoma. Since this is the first time LTZ-301 is being tried in humans, detailed safety information from previous human studies is not available. However, the U.S. Food and Drug Administration (FDA) has approved the initial testing of LTZ-301 in humans, indicating it was considered safe enough to begin trials.

The trial aims to find the safest dose and assess how well people tolerate LTZ-301. This includes monitoring for any side effects and understanding how the body reacts to the drug. As this is an early-stage trial, the main focus is on safety and participant tolerance, which are being closely monitored. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

LTZ-301 is unique because it targets non-Hodgkin's lymphoma with a novel mechanism of action that differs from traditional chemotherapy and immunotherapy options. Unlike standard treatments that often involve broad-spectrum approaches, LTZ-301 is designed to home in on specific pathways involved in lymphoma cell growth, potentially reducing side effects and increasing effectiveness. Researchers are excited about LTZ-301 because it offers the possibility of improved tolerability and safety, with its ability to be dosed at various levels to optimize clinical activity for different lymphoma types.

What evidence suggests that LTZ-301 might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that LTZ-301 targets a specific part of B-cells, which play a crucial role in the immune system. This treatment guides monocytes and macrophages to attack and destroy cancerous B-cells. Early results suggest this method can reduce cancer cells in non-Hodgkin's lymphoma. Although human studies have provided limited information so far, this approach is promising because it leverages the body’s own immune system to combat cancer. LTZ-301 offers hope for treating non-Hodgkin lymphoma that has recurred or is unresponsive to other treatments. Participants in this trial will join one of the treatment arms—Dose Escalation, Backfill Expansion, or Expansion—to explore the safety, tolerability, and clinical activity of LTZ-301. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with B-cell non-Hodgkin lymphoma that has come back or didn't respond to previous treatments. Specific types of lymphomas are included, such as MALT, Mantle Cell, Follicular, and Diffuse Large B-Cell Lymphomas among others.

Inclusion Criteria

I am 18 years old or older.

At least 1 bi-dimensionally measurable lesion (≥ 1.5 cm) in longest dimension

My condition did not improve after two different treatments.

Exclusion Criteria

I have not received CAR-T therapy in the last 60 days.

My condition is either CLL or Richter's transformation.

I have had a solid organ transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Subjects participate in one of eight escalating defined dose level cohorts, receiving up to 54 weeks of LTZ-301 intravenously

Up to 54 weeks

Expansion

A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LTZ-301

Trial Overview The study tests LTZ-301's safety and how well it works against different types of non-Hodgkin lymphoma. It's an early-stage trial (Phase 1) where participants receive LTZ-301 to assess its effects on their cancer.

How Is the Trial Designed?

Group I: Expansion Experimental Treatment 1 Intervention

A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type.

Group II: Dose Escalation Experimental Treatment 1 Intervention

Subjects in this arm will participate in one (1) of eight (8) escalating defined dose level cohorts. Subjects will receive up to 54 weeks of LTZ-301 intravenously.

Group III: Backfill Expansion Experimental Treatment 1 Intervention

Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.

Who Is Running the Clinical Trial?

LTZ Therapeutics, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07121946

This is a Phase 1 Study to Evaluate the Safety of LTZ-301 ... This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma. ClinicalTrials.gov ID NCT07121946. Sponsor LTZ ...

2. targetedonc.com targetedonc.com/view/fda-clears-ind-application-for-ltz-301-in-non-hodgkin-lymphoma

FDA Clears IND Application for LTZ-301 in non-Hodgkin ... A phase 1, open-label, multicenter study of LTZ-301 for treating R/R NHL is planned to begin in the second quarter of 2025. The FDA has granted ...

3. ltztherapeutics.com ltztherapeutics.com/html/news/118.html

LTZ Therapeutics Announces FDA Clearance of IND ... LTZ-301 works by redirecting monocytes and macrophages toward CD79b+ B-cells, leading to enhanced phagocytosis and depletion of cancer cells.

4. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/ltz-301-first-in-class-myeloid-engager-immunotherapy-ind-cleared-by-fda/

LTZ-301: First-in-Class Myeloid Engager Immunotherapy ... LTZ-301, a first-in-class myeloid engager immunotherapy, will be investigated for the treatment of relapsed or refractory non-Hodgkin lymphoma (r/r NHL).

5. ctsearchsupport.org ctsearchsupport.org/clinical-trials/this-is-a-phase-1-study-to-evaluate-the-safety-of-ltz-301-in-patients-with-non-hodgkin-lymphoma

A drug, LTZ-301, to treat non-Hodgkin lymphoma (NHL ... LTZ-301 is a bispecific myeloid engager antibody that targets CD79b on certain cells. You'll get treatment in cycles that last 1 month. In each ...

6. ctv.veeva.com ctv.veeva.com/study/a-phase-1-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 ... This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, ...