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GD2-CART01 was the first CAR-T to produce durable complete remissions in a childhood solid tumour: two-thirds responded and a third achieved complete remission.
NEJM 2023: ORR 63%, CR 33%; 3-year OS 60%, EFS 36%; grade 1-2 CRS common, one grade 3; safety switch not needed. Nature Medicine 2025 long-term update: ORR 66%, complete responses sustained 8-18+ years in earlier-generation recipients, and 5 of 8 patients treated in remission disease-free at 10-15 years. Phase 2 expansion and commercialisation (Italy) under way.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric).
Shares High-risk neuroblastoma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric).
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Neuroblastoma (paediatric).
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
Shares Armoured, logic-gated & next-gen CARs, Neuroblastoma (paediatric), CAR-T cell therapy.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/