NCT06285422

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

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Sana Biotechnology · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	SC262	SC262 is an allogeneic CAR -T cell therapy

Timeline

• Start date: 2024-04-18
• Primary completion: 2025-12-01
• Completion: 2029-03-01
• First posted: 2024-02-29
• Last updated: 2025-11-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study