Evaluating SC262 for Non-Hodgkin's Lymphoma
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)
This study is testing a new treatment called SC262 in people with Non-Hodgkin's Lymphoma who have already had a specific type of therapy, to see if it's safe and how well it works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sana Biotechnology Industry-sponsored |
| Drugs / interventions | CAR T, chemotherapy, prednisone, Chimeric Antigen Receptor, cyclophosphamide, fludarabine |
| Locations | 3 sites (Kansas City, Kansas and 2 other locations) |
| Trial ID | NCT06285422 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study aims to assess the safety and tolerability of SC262 in patients with Non-Hodgkin's Lymphoma who have previously undergone limited CD19-directed CAR T cell therapy. Participants will receive SC262 intravenously after a lymphodepleting chemotherapy regimen. The study consists of two parts: a dose-finding phase using a 3+3 design and a dose expansion phase to further evaluate safety and efficacy in patients with Large B-Cell Lymphoma. The study will also explore cellular kinetics, immunogenicity, and potential biomarkers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with relapsed or refractory Non-Hodgkin's Lymphoma who have received no more than one prior CD19-directed CAR T cell therapy.
Not a fit: Patients who have undergone prior CD22-directed therapies or have a poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory Non-Hodgkin's Lymphoma.
How similar studies have performed: Other studies involving CAR T cell therapies have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kansas City, Kansas and 2 other locations
- The University of Kansas Hospital — Kansas City, Kansas, United States (Recruiting)
- Swedish Cancer Institute — Seattle, Washington, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Sana Biotechnology, Inc
- Email: vivid@sana.com
- Phone: (206) 791 3731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.