Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID) (VIVID)

November 21, 2025 updated by: Sana Biotechnology

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)

SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SC262 Plus Chemotherapy Regimen
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262
Drug: SC262
SC262 is an allogeneic CAR -T cell therapy
Other Names:
  • Cyclophosphamide
  • Fludarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate safety and tolerability of SC262
Time Frame: 24 months
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate preliminary anti-tumor activity of SC262
Time Frame: 24 months
Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response)
24 months
Evaluate cellular kinetics and persistence of SC262
Time Frame: 24 months
Cellular kinetics related peak (Cmax) in peripheral blood
24 months
Evaluate cellular kinetics and persistence of SC262
Time Frame: 24 months
Cellular kinetics-related parameters evaluated by CAR T cell copy number
24 months
Evaluate cellular kinetics and persistence of SC262
Time Frame: 24 months
Area under the concentration time curve (AUC) in peripheral blood
24 months
Evaluate host immunogenicity to SC262
Time Frame: 24 months
Incidence of anti-CD19-directed CAR antibodies
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Biotechnology

Investigators

  • Study Director: John Gerecitano, MD, PhD, Sana Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC262-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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