2024-516211-25-00RecruitingPhase 1/2
A long-term monitoring study of patients suffering from a malignant neoplasm of the central nervous system previously treated with hematopoietic stem cells
A follow-up study evaluating the long term safety of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-α2 gene previously administered to patients with glioblastoma multiforme
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary objective is to evaluate the long term mutagenic safety of Temferon.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 1 Aug 2024
- Start date
- 27 Oct 2022
- Lead sponsor
- Genenta Science S.p.A.
- Diseases
- Glioblastoma
- EU CT number
- 2024-516211-25-00
- EudraCT number
- 2021-000700-38
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 5
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- There are no exclusion criteria for this study
Who the study is looking for
- Patients who have received Temferon and completed the follow-up in the TEM-GBM_001 study.
- Able and willing to provide written informed consent and comply with the study protocol and procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.