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NCT06285422 | RECRUITING | Non Hodgkin's Lymphoma

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

Sana Biotechnology

Brief Summary:

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

Condition or disease

Non Hodgkin's Lymphoma

Large B-cell Lymphoma

Intervention/treatment

SC262

Phase

PHASE1

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
Estimated Enrollment : 35 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-04-18
Estimated Primary Completion Date : 2028-03
Estimated Study Completion Date : 2029-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID)

Location Details

NCT06285422

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How to Participate

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Locations

RECRUITING

United States, Kansas

The University of Kansas Hospital

Kansas City, Kansas, United States, 66160

RECRUITING

United States, Washington

Swedish Cancer Institute

Seattle, Washington, United States, 98104

RECRUITING

United States, Washington

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109