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TCRaß+CD19+ depleted haploidentical stem cell transplantation followed by immunotherapy in patients with relapsed/resistant high-risk neuroblastoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519089-32-02
Acronym
APLOaß-NB
Enrollment
19
Registered
2025-01-31
Start date
2023-08-29
Completion date
Unknown
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient affected by high risk Neuroblastoma relapsed or in progression after first line treatment.

Brief summary

Overall Survival (OS)

Detailed description

Engraftment and donor chimerism analysis, Immune reconstitution (+30, +60, +90, +120, +180, +360), Infectious events, Transplant-related mortality (TRM), Progression-free Survival (PFS), Early and late transplant-related toxicities, Immunotherapy (antui-GD2 mAb)–related toxicities, Donor-derived NK-cells infusion–related toxicities, Disease response (INRC criteria), Acute and chronic GvHD, Antitumor activity of donor-derived NK-cells (graft-versus-tumor effect), Relevance of the donor NK cell selection criteria

Interventions

DRUGRixathon 100 mg concentrate for solution for infusion
DRUGAplo-TCSE TCRaß+CD19+ depleto
DRUGAllogeneic peripheral blood-derived NK cells CD3- CD56+
DRUGQarziba 4.5 mg/mL concentrate for solution for infusion
DRUGMelfalan Tillomed 50 mg polvere e solvente per soluzione iniettabile/infusione
DRUGTEPADINA 100 mg powder for concentrate for solution for infusion
DRUGFludarabina Accord 25 mg/ml Concentrato per soluzione iniettabile o per infusione
DRUGGrafalon 20 mg/ml concentrato per soluzione per infusione

Sponsors

IRCCS Istituto Giannina Gaslini
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS)—

Secondary

MeasureTime frame
Engraftment and donor chimerism analysis, Immune reconstitution (+30, +60, +90, +120, +180, +360), Infectious events, Transplant-related mortality (TRM), Progression-free Survival (PFS), Early and late transplant-related toxicities, Immunotherapy (antui-GD2 mAb)–related toxicities, Donor-derived NK-cells infusion–related toxicities, Disease response (INRC criteria), Acute and chronic GvHD, Antitumor activity of donor-derived NK-cells (graft-versus-tumor effect), Relevance of the donor NK cell selection criteria—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026