ACTIVE_NOT_RECRUITING

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

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Conditions

Non Hodgkin's LymphomaLarge B-cell LymphomaCAR T Cell TherapyMantle Cell LymphomaFollicular LymphomaMarginal Zone LymphomaHigh-Grade B-Cell LymphomaPrimary Mediastinal B-Cell LymphomaDiffuse Large B-Cell LymphomaNon-Hodgkin's LymphomaAllogeneicHypoimmuneCD22SC262

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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)

Quick Facts

Study Start:2024-04-18
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06285422

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or Female Subject aged 18-80 years at the time of signing the informed consent
  2. 2. Histologic diagnosis of NHL (based on World Health Organization 2016 criteria) including:
  3. * 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
  4. * FL
  5. * Marginal Zone Lymphomas (MZL)
  6. * Mantle Cell Lymphoma (MCL)
  7. 3. Relapsed or refractory disease after no more than 1 prior CD19-directed CAR T cell therapy
  8. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  9. 5. At least 1 measurable (PET-positive) lesion per Lugano classification
  10. 6. Life expectancy ≥12 Weeks
  1. 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. 2. History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment.
  3. 3. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time)
  4. 4. Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as \>10 mg/day prednisone or equivalent)
  5. 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.

Contacts and Locations

Principal Investigator

John Gerecitano, MD, PhD
STUDY_DIRECTOR
Sana Biotechnology, Inc.

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Sana Biotechnology

  • John Gerecitano, MD, PhD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-04-18
Study Completion Date2029-03

Study Record Updates

Study Start Date2024-04-18
Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Non Hodgkin's Lymphoma
  • Large B-cell Lymphoma