Large B-cell Lymphoma, Non Hodgkin's Lymphoma
Conditions
Keywords
Large B-Cell Lymphoma, CAR T Cell Therapy, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, High-Grade B-Cell Lymphoma, Primary Mediastinal B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma, Allogeneic, Hypoimmune, CD22, SC262
Brief summary
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
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).
Interventions
DRUGSC262
SC262 is an allogeneic CAR -T cell therapy
Sponsors
Sana Biotechnology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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
1. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate safety and tolerability of SC262 | 24 months | Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate preliminary anti-tumor activity of SC262 | 24 months | Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response) |
| Evaluate cellular kinetics and persistence of SC262 | 24 months | Cellular kinetics related peak (Cmax) in peripheral blood |
| Evaluate host immunogenicity to SC262 | 24 months | Incidence of anti-CD19-directed CAR antibodies |
Countries
United States
Outcome results
None listed