Study Evaluating SC262 in Subjects with R/r Non-Hodgkin's Lymphoma (VIVID)
Purpose
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Conditions
- Non Hodgkin's Lymphoma
- Large B-cell Lymphoma
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or Female Subject aged 18-80 years at the time of signing the informed consent 2. 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) 3. Relapsed or refractory disease after no more than 1 prior CD19-directed CAR T cell therapy 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. At least 1 measurable (PET-positive) lesion per Lugano classification 6. 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) 2. History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment. 3. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time) 4. Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >10 mg/day prednisone or equivalent) 5. 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SC262 Plus Chemotherapy Regimen |
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262 |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Sana Biotechnology
Detailed 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).