This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LTZ-301, LTZ-301, LTZ-301.
- Who it may be relevant to
- Registry conditions: Non-Hodgkin Lymphoma Refractory/ Relapsed, DLBCL - Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma (MCL), Follicular Lymphoma ( FL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Overview
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
Detailed description
LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis
Interventions
- Biological LTZ-301
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. - Biological LTZ-301
LTZ-301will be dosed IV, as above - Biological LTZ-301
LTZ-301will be dosed IV, as above
Primary outcome measures
- Safety and Tolerability [Time frame: Up to 54 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- City of Hope — Duarte
- Washington University School of Medicine — St Louis
- Roswell Park Cancer Institute — Buffalo
- Memorial Sloan Kettering Cancer Center - Bergen — New York
- Tennessee Oncology — Nashville
- Fred Hutchinson Cancer Center — Seattle
Identifiers
NCT: NCT07121946 · LTZ-301-001