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Tests treatment safety and results for Non-Hodgkin Lymphoma Refractory/ Relapsed
Official title This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT07121946
What this study is testing
What is LTZ-301?
LTZ-301 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma refractory/ relapsed.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; St Louis, Missouri, United States; Buffalo, New York, United States; Nashville, Tennessee, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.