SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor
activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05878184.
This is an open-label, single arm, Phase 1, first-in-human (FIH) study to evaluate the
safety and tolerability of SC291 administered intravenously (IV) following a standard
lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with
NHL or CLL who have received two or more prior systemic treatments per standard of care
(or after autologous stem cell transplant [ASCT] for NHL). This study will be conducted
in 2 parts. Phase 1a: dose finding using a 3+3 design in subjects with NHL or CLL. Phase
1b: dose expansion to further evaluate safety and efficacy at the RP2D in subjects with
LBCL and CLL.
Lead OrganizationSana Biotechnology