SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
SC291 is an allogeneic CAR-T cell therapy
City of Hope
Duarte, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Northside Hospital
Atlanta, Georgia, United States
Evaluate safety and tolerability of SC291
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Time frame: 24 months
Evaluate preliminary anti-tumor activity of SC291
Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response)
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC291
Cellular kinetics-related parameters evaluated by CAR T cell copy number
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC291
Cellular kinetics related peak (Cmax) in peripheral blood
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC291
Area under the concentration time curve (AUC) in peripheral blood
Time frame: 24 months
Evaluate host immunogenicity to SC291
Incidence of anti-CD19-directed CAR antibodies
Time frame: 24 months
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University of Kansas Medical Center
Fairway, Kansas, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
MD Anderson Cancer Center
Houston, Texas, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia