Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
244
Countries
2
Sites
3
B-cell Mediated Autoimmune Diseases
Key facts
- Sponsor
- Fate Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 26 Jan 2026 → ongoing
- Decision date (initial)
- 2025-10-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517397-25-00
- ClinicalTrials.gov
- NCT06308978
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
B-cell Mediated Autoimmune Diseases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fate Therapeutics Inc.
- Sponsor organisation
- Fate Therapeutics Inc.
- Address
- 12278 Scripps Summit Drive
- City
- San Diego
- Postcode
- 92131-3697
- Country
- United States
Scientific contact point
- Organisation
- Fate Therapeutics Inc.
- Contact name
- Rebecca Elstrom
Public contact point
- Organisation
- Fate Therapeutics Inc.
- Contact name
- Fate Trial Disclosure
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 20 | 1 |
| Sweden | Ongoing, recruiting | 30 | 2 |
| Rest of world
United States, United Kingdom
|
— | 194 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Médecine Interne, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-01-30 | ||||
| Sweden | 2026-01-26 | 2026-04-08 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-22 | Sweden | Acceptable 2025-09-29
|
2025-09-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-07 | Acceptable | 2025-11-17 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-09 | Sweden | Acceptable | 2025-12-08 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-11-07 | 2026-02-16 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-20 | Acceptable | 2025-11-28 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-04 | Sweden | Acceptable | 2026-03-04 |