SC262-101 is a Phase 1 study to evaluate SC262 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 SC262 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with Non Hodgkin's Lymphoma (NHL) who have received no more than 1 prior CD19-directed Chimeric Antigen Receptor T-Cells (CAR T) cell therapy. This study will be conducted in 2 parts. Dose finding using a 3+3 design in subjects with NHL. Dose expansion to further evaluate safety and efficacy at the recommended phase 2 dose (RP2D) in subjects with Large B-Cell Lymphoma (LBCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
SC262 is an allogeneic CAR -T cell therapy
The University of Kansas Hospital
Kansas City, Kansas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Evaluate safety and tolerability of SC262
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Time frame: 24 months
Evaluate preliminary anti-tumor activity of SC262
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 SC262
Cellular kinetics related peak (Cmax) in peripheral blood
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC262
Cellular kinetics-related parameters evaluated by CAR T cell copy number
Time frame: 24 months
Evaluate cellular kinetics and persistence of SC262
Area under the concentration time curve (AUC) in peripheral blood
Time frame: 24 months
Evaluate host immunogenicity to SC262
Incidence of anti-CD19-directed CAR antibodies
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.