2024-519089-32-02RecruitingPhase 2
TCRaß+CD19+ depleted haploidentical stem cell transplantation followed by immunotherapy in patients with relapsed/resistant high-risk neuroblastoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the safety and efficacy of haploidentical stem cell transplantation with alfa-beta-CD19+ depletion folowed by immunotherapy with donor-NK cells infusion and anti-GD2 moAb in patients with high risk Neuroblastoma relapsed or in progression disease after first line treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 29 Aug 2023
- Lead sponsor
- IRCCS Istituto Giannina Gaslini
- Diseases
- Neuroblastoma
- EU CT number
- 2024-519089-32-02
- EudraCT number
- 2022-000488-27
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 19
- 1 site 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 illness
- Disease progressing after salvage therapy.
Other
- Severe organ dysfunction, defined as grade 4 or higher dysfunctions according to international reference tables (CTCAE v 5.0).
- Life expectancy of less than 3 months.
Who the study is looking for
- High-risk neuroblastoma (stage 4 with age > 12 months at diagnosis, or stage 2, 3, 4s with MYCN amplification) in local, metastatic or combined recurrence after first-line therapy protocol
- Stabilization of disease (at or above STABLE DISEASE according to INRC criteria) achieved after salvage chemotherapy according to the center’s clinical practice
- Availability of a suitable HLA haploidentical familial donor to perform HSC donation from peripheral blood after stimulation with GCSF (+/-Plerixafor)
- Informed parental or legal guardian consent
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto Giannina Gaslini | Genoa | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.