Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
27
Countries
1
Sites
3
Glioblastoma multiforme
Key facts
- Sponsor
- Genenta Science S.p.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Mar 2019 → ongoing
- Decision date (initial)
- 2024-02-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-510299-29-00
- EudraCT number
- 2018-001404-11
- ClinicalTrials.gov
- NCT03866109
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma multiforme
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
| 20.0 | PT | 10018337 | Glioblastoma multiforme | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genenta Science S.p.A.
- Sponsor organisation
- Genenta Science S.p.A.
- Address
- Via Olgettina 58
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Genenta Science S.p.A.
- Contact name
- Genenta Science
Public contact point
- Organisation
- Genenta Science S.p.A.
- Contact name
- Genenta Science
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 27 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Ospedale San Raffaele S.r.l.
U.O. Ematologia e Trapianto Midollo Osseo, Via Olgettina 60, 20132, Milan
IRCCS Foundation Istituto Neurologico Carlo Besta
U.O. Neurologia VIII - Neuro-oncologia Molecolare, Via Giovanni Celoria 11, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Scienze dell'Invecchiamento, Neurologiche, Ortopediche e della Testa-Collo, Largo Francesco Vito 1, 00168, Rome
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 |
|---|---|---|---|---|---|
| Italy | 2019-03-13 | 2019-04-12 | 2026-01-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-26 | Italy | Acceptable 2024-02-22
|
2024-02-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-09 | Italy | Acceptable 2024-02-22
|
2024-09-09 |