Safety testing of LTZ-301 in adults with relapsed or refractory B‑cell non-Hodgkin lymphoma
Official title: A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Run by LTZ Therapeutics, Inc. · NCT07121946 · Data updated 2026-11-12
This trial will test whether LTZ-301 is safe and how it behaves in adults whose B‑cell non-Hodgkin lymphoma has come back or not responded after at least two prior treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | LTZ Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 6 sites (Duarte, California and 5 other locations) |
| Status | Recruiting |
| Started | January 29, 2026 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07121946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with relapsed or refractory B‑cell non-Hodgkin lymphoma (including DLBCL, MCL, FL, MZL) who have had at least two prior systemic regimens, have at least one measurable lesion, ECOG 0–1, and adequate organ function are ideal candidates.
✕Probably not a fit
Patients with CLL or Richter transformation, current CNS lymphoma, recent allogeneic transplant or recent CAR-T or ASCT, active autoimmune disease, uncontrolled cardiovascular disease, HIV seropositivity, or other recent malignancies are excluded and may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-human, Phase 1, multicenter, open-label trial gives single-agent LTZ-301 to adults with relapsed or refractory B‑cell non-Hodgkin lymphoma to determine safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity. LTZ-301 is a bispecific myeloid cell engager that targets B cells via CD79B and is designed to trigger phagocytosis. Eligible participants must be adults with measurable disease, ECOG 0–1, adequate organ function, and prior exposure to at least two systemic regimens. Treatment is administered at participating U.S. cancer centers with monitoring for adverse events and tumor response.
Why it matters
Potential benefit: If successful, LTZ-301 could provide a new treatment option that uses myeloid-mediated phagocytosis to clear malignant B cells in patients with relapsed or refractory B‑cell NHL.
How similar studies have gone: Other CD79B-directed therapies (for example, antibody–drug conjugates) have shown clinical activity in B‑cell NHL and bispecific/myeloid-engaging approaches are an emerging area with early signs of activity but remain less tested in humans.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
City of Hope
Duarte, California, United States Recruiting -
Washington University School of Medicine
St Louis, Missouri, United States Recruiting -
Roswell Park Cancer Institute
Buffalo, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center - Bergen
New York, New York, United States Recruiting -
Tennessee Oncology
Nashville, Tennessee, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Sherry Unabia
- Email: sherry.unabia@ltztherapeutics.com
- Phone: 669-207-0084
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.