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
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
CLL, or Richters transformation
Prior solid organ transplant
Prior allogeneic stem cell transplant
ASCT within 100 days prior to the first LTZ-301 administration
Sequential
LTZ-301
Biological/VaccineLTZ-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-301
Biological/VaccineLTZ-301will be dosed IV, as above
LTZ-301
Biological/VaccineLTZ-301will be dosed IV, as above
Safety and Tolerability
To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria.
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