Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
60
Countries
2
Sites
4
Relapsed/Refractory Hematologic Autoimmune Disease
Key facts
- Sponsor
- CRISPR Therapeutics AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2026-03-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-523845-90-00
- WHO UTN
- U1111-1328-3996
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory Hematologic Autoimmune Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10087092 | Warm autoimmune hemolytic anemia | 100000004848 |
| 23.0 | LLT | 10074667 | Immune thrombocytopenic purpura | 10005329 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CRISPR Therapeutics AG
- Sponsor organisation
- CRISPR Therapeutics AG
- Address
- Baarerstrasse 14
- City
- Zug
- Postcode
- 6300
- Country
- Switzerland
Scientific contact point
- Organisation
- CRISPR Therapeutics AG
- Contact name
- Medical Affairs
Public contact point
- Organisation
- CRISPR Therapeutics AG
- Contact name
- Medical Affairs
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 30 | 3 |
| Spain | Authorised, recruitment pending | 15 | 1 |
| Rest of world
United States
|
— | 15 | — |
Investigational sites
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
II. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Koeln AöR
Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-31 | Germany | Acceptable with conditions 2026-03-09
|
2026-03-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-19 | Germany | Acceptable with conditions | 2026-04-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-24 | Acceptable with conditions | 2026-04-21 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-07 | Germany | Acceptable with conditions | 2026-05-07 |