Large B-cell Lymphoma Clinical Trial
Official title:
A Phase 1 Study Evaluating SC262, a Hypoimmune, Allogeneic CD22-directed CAR T Cell Therapy, in Relapsed and/or Refractory Non-Hodgkin's Lymphoma (VIVID)
NCT number | NCT06285422 |
Other study ID # | SC262-101 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | March 2029 |
Verified date | May 2024 |
Source | Sana Biotechnology |
Contact | Ndidi Onwudiwe |
Phone | (206) 791 3731 |
vivid[@]sana.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | March 2029 |
Est. primary completion date | March 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Swedish Cancer Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Sana Biotechnology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate safety and tolerability of SC262 | Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities | 24 months | |
Secondary | Evaluate preliminary anti-tumor activity of SC262 | Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response) | 24 months | |
Secondary | Evaluate cellular kinetics and persistence of SC262 | Cellular kinetics related peak (Cmax) in peripheral blood | 24 months | |
Secondary | Evaluate cellular kinetics and persistence of SC262 | Cellular kinetics-related parameters evaluated by CAR T cell copy number | 24 months | |
Secondary | Evaluate cellular kinetics and persistence of SC262 | Area under the concentration time curve (AUC) in peripheral blood | 24 months | |
Secondary | Evaluate host immunogenicity to SC262 | Incidence of anti-CD19-directed CAR antibodies | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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