A Phase 1 Study of FT819 in Participants with Moderate to Severe Active Systemic Lupus Erythematosus

Return to Grants

Grant Award Details

Grant Number:
CLIN2-16303
Investigator(s):
Name:
Type:
PI

Human Stem Cell Use:
Award Value:
$7,934,448
Status:
Active

Grant Application Details

Application Title:

A Phase 1 Study of FT819 in Participants with Moderate to Severe Active Systemic Lupus Erythematosus

Public Abstract:
Therapeutic Candidate or Device

iPSC-derived CD19 CAR T cell therapy

Indication

Systemic Lupus Erythematosus

Therapeutic Mechanism

Depletion of CD19+ B cells and plasmablasts

Unmet Medical Need

Potential for drug-free remission and reset of the immune system

Project Objective

Phase 1 trial completed

Major Proposed Activities

  • Site Activation and Patient Enrollment
  • Clinical Trial Data Monitoring, Database Maintenance, and Data Analysis
  • Drug Product Manufacturing
Statement of Benefit to California:
By 1) advancing the development of a potentially curative therapy for a devastating disease which disproportionally affects minorities and underserved communities, 2) enabling access to study participation for California citizens through the multiple California sites included in the project plan, 3) supporting the leadership of California technology companies in the field of iPSC-derived cell therapy and related regenerative medicine fields, and the related tax and economic growth opportunities.