Active — Not RecruitingPhase 1

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

United States6 participantsStarted 2024-04-18

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male or Female Subject aged 18-80 years at the time of signing the informed consent
✓. Histologic diagnosis of NHL (based on World Health Organization 2016 criteria) including:
✓. 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

Exclusion criteria

✕. 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)
✕. History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment.
✕. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time)
✕. Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as \>10 mg/day prednisone or equivalent)
✕. 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.

What they're measuring

Evaluate safety and tolerability of SC262

Timeframe: 24 months

Trial details

NCT IDNCT06285422

SponsorSana Biotechnology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Non Hodgkin's Lymphoma trials