Your session is about to expire
← Back to Search
CAR T-cell Therapy
SC262 for Non-Hodgkin's Lymphoma (VIVID Trial)
Phase 1
Recruiting
Research Sponsored by Sana Biotechnology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Male or Female Subject aged 18-80 years at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of SC262 in treating tumors.
Who is the study for?
This trial is for adults aged 18-80 with certain B-cell malignancies, including various types of non-Hodgkin's lymphoma and mantle cell lymphoma. Participants must have relapsed or refractory disease after no more than one prior therapy, a life expectancy of at least 12 weeks, and be physically capable (ECOG status 0-1).
What is being tested?
The study is testing SC262, a new treatment for B-cell malignancies. It's in Phase 1 to check its safety, how well it works against cancer cells, what the body does to it over time, if it causes immune reactions and to look at some early signs that might predict who benefits.
What are the potential side effects?
As this is an early-phase trial for SC262, specific side effects are not yet fully known but may include typical reactions related to immune therapies such as fatigue, feverish symptoms or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate safety and tolerability of SC262
Secondary study objectives
Evaluate cellular kinetics and persistence of SC262
Evaluate host immunogenicity to SC262
Evaluate preliminary anti-tumor activity of SC262
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SC262 Plus Chemotherapy RegimenExperimental Treatment1 Intervention
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262
Find a Location
Who is running the clinical trial?
Sana BiotechnologyLead Sponsor
4 Previous Clinical Trials
12,054 Total Patients Enrolled
Cori Abikoff, MDStudy DirectorSana Biotechnology, Inc.
1 Previous Clinical Trials
16 Total Patients Enrolled
Hosein Kouros-MehrStudy DirectorSana Biotechnology, Inc.
Share this study with friends
Copy Link
Messenger