Non-Hodgkin Lymphoma Refractory/ RelapsedPhase 1NCT07121946
This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
A Phase 1 study testing LTZ-301 in people with Non-Hodgkin Lymphoma Refractory/ Relapsed and DLBCL - Diffuse Large B Cell Lymphoma, run by LTZ Therapeutics, Inc. at 6 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma Refractory/ Relapsed, DLBCL - Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma (MCL)
- What is being tested?
- LTZ-301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Jan 2026to Feb 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Francisco Hernandez, MD, 716-845-2300 ext. 1359, Francisco.Hernandez@RoswellPark.org
- Recruiting
City of Hope
Duarte, California, 91010
Elizabeth Budde, MD, 626-218-2405, ebudde@coh.org
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Michael Byrne, DO, 888-550-2835, mbyrne@tnonc.com
- Recruiting
Memorial Sloan Kettering Cancer Center - Bergen
New York, New York, 10065
Pallawi Torka, MD, 201-775-7808, torkap@mskcc.org
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Ajay Gopal, MD, 206-606-2037, agopal@uw.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Anne Fischer, 314-362-3021, afischer@wustl.edu
About this study
Official title: A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
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
Read the detailed description
LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis
- Conditions
- Non-Hodgkin Lymphoma Refractory/ Relapsed, DLBCL - Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma (MCL), Follicular Lymphoma ( FL), Marginal Zone Lymphoma (MZL)
- Being tested
- LTZ-301
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTZ-301Biological
LTZ-301 will be dosed IV, in initial 28 day cycles. First cycle dosing is every week. Second through fifth cycles are dosed every 2 weeks. Sixth cycle and beyond are 21 day cycles, and are dosed once every 3 weeks.
LTZ-301Biological
LTZ-301will be dosed IV, as above
LTZ-301Biological
LTZ-301will be dosed IV, as above
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 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. Receives: Biological: LTZ-301 |
| Backfill Expansion | Experimental | Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels. Receives: Biological: LTZ-301 |
| Expansion | Experimental | A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type. Receives: Biological: LTZ-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria.
Measured: Up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start29 Jan 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma Refractory/ RelapsedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LTZ Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121946
- Sponsor's protocol ID
- LTZ-301-001
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No