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Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID)
Trial Status: active
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor
activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
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:
LBCL, including Diffuse Large B Cell Lymphoma (DLBCL) not otherwise specified (NOS) (including DLBCL arising from indolent lymphoma), Primary Mediastinal Large B-Cell Lymphoma (PMBCL), High-Grade B-Cell Lymphoma (HGBCL), and Follicular Lymphoma (FL) Grade 3B
FL
Marginal Zone Lymphomas (MZL)
Mantle Cell Lymphoma (MCL)
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
Prior CD22-directed therapy including CD22-directed CAR T cell therapy or other CD22 -directed antibody or cell therapy (e.g., Natural Killer (NK) cell)
History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment.
Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time)
Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >10 mg/day prednisone or equivalent)
History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, within 12 months of enrollment.
Additional locations may be listed on ClinicalTrials.gov for NCT06285422.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
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
