A Phase 1 Study of FT819 in Participants with Moderate to Severe Active Systemic Lupus Erythematosus
Grant Award Details
Grant Type:
Grant Number:
CLIN2-16303
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$7,934,448
Status:
Pre-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
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.