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

Description

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

Conditions

Non Hodgkin's Lymphoma, Large B-cell Lymphoma

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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)

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

Condition
Non Hodgkin's Lymphoma
Intervention / Treatment

-

Contacts and Locations

Kansas City

The University of Kansas Hospital, Kansas City, Kansas, United States, 66160

Seattle

Swedish Cancer Institute, Seattle, Washington, United States, 98104

Seattle

Fred Hutchinson Cancer Center, Seattle, Washington, United States, 98109

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sana Biotechnology,

Cori Abikoff, MD, STUDY_DIRECTOR, Sana Biotechnology, Inc.

Study Record Dates

2029-03