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SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Full description
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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or Female Subject aged 18-80 years at the time of signing the informed consent
Histologic diagnosis of NHL (based on World Health Organization 2016 criteria) including:
Relapsed or refractory disease after no more than 1 prior CD19-directed CAR T cell therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
At least 1 measurable (PET-positive) lesion per Lugano classification
Life expectancy ≥12 Weeks
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
35 participants in 1 patient group
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Central trial contact
Ndidi Onwudiwe; Barbara Martello
Data sourced from clinicaltrials.gov
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