Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
34
Countries
2
Sites
5
Refractory/Relapsing B-Cell Malignancies
Key facts
- Sponsor
- Interius Biotherapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Aug 2025 → 18 Mar 2026
- Decision date (initial)
- 2024-12-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509132-26-00
- WHO UTN
- U1111-1303-9462
- ClinicalTrials.gov
- NCT06539338
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Refractory/Relapsing B-Cell Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000845 | Acute lymphoblastic leukemia | 10029104 |
| 25.0 | LLT | 10086816 | B-cell non-Hodgkin´s lymphoma refractory | 100000004848 |
| 20.0 | PT | 10076866 | Acute lymphocytic leukaemia refractory | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Interius Biotherapeutics Inc.
- Sponsor organisation
- Interius Biotherapeutics Inc.
- Address
- 3401 Grays Ferry Avenue Building 200 Office 300
- City
- Philadelphia
- Postcode
- 19146-2701
- Country
- United States
Scientific contact point
- Organisation
- Interius Biotherapeutics Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Interius Biotherapeutics Inc.
- Contact name
- EU CT Support
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 10 | 3 |
| Spain | Ended | 6 | 2 |
| Rest of world
United States, Australia
|
— | 18 | — |
Investigational sites
Universitaetsklinikum Essen AöR
Department of Hematology and Stem Cell Transplantation, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Erlangen AöR
Medicine 5 - Hematology/Oncology, Ulmenweg 18, Innenstadt, Erlangen
Klinikum der Universitaet Muenchen AöR
Med. Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 | 2025-08-08 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-01 | Germany | Acceptable 2024-12-11
|
2024-12-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-24 | Germany | Acceptable 2025-07-14
|
2025-07-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-16 | Germany | Acceptable 2025-07-14
|
2025-09-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-29 | Germany | Acceptable 2025-11-17
|
2025-11-18 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-21 | Germany | Acceptable 2025-11-17
|
2025-11-21 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-13 | Acceptable 2026-03-23
|
2026-03-24 |