RECRUITINGPhase 1INTERVENTIONAL
This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 Should NOT Join This Trial:
- 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 weakened immune system virus (HIV) seropositivity
- Active autoimmune conditions (where your immune system attacks your own body)
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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
Locations (5)
City of Hope
Duarte, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Tennessee Oncology
Nashville, Tennessee, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States