Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
18
Countries
1
Sites
2
Refractory Progressive Multiple Sclerosis
Key facts
- Sponsor
- Autolus Limited
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 3 Nov 2025 → ongoing
- Decision date (initial)
- 2025-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Refractory Progressive Multiple Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10053395 | Progressive multiple sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Autolus Limited
- Sponsor organisation
- Autolus Limited
- Address
- 191 Wood Lane
- City
- London
- Postcode
- W12 7FP
- Country
- United Kingdom
Scientific contact point
- Organisation
- Autolus Limited
- Contact name
- Jonathan Willmer
Public contact point
- Organisation
- Autolus Limited
- Contact name
- Jonathan Willmer
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 3 | 2 |
| Rest of world
United States, United Kingdom
|
— | 15 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2025-11-03 | 2025-11-03 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-14 | Spain | Acceptable 2025-06-26
|
2025-06-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-08 | Spain | Acceptable 2025-09-18
|
2025-09-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-06 | Spain | Acceptable 2025-09-18
|
2026-02-06 |