The DOI matches its Crossref record; 31 of the 31 references it cites were found in a registry or an index.
GD2-CART01 for Relapsed or Refractory High-Risk Neuroblastoma
Abstract
Immunotherapy with chimeric antigen receptor (CAR)–expressing T cells that target the disialoganglioside GD2 expressed on tumor cells may be a therapeutic option for patients with high-risk neuroblastoma. Download a PDF of the Research Summary. In an academic, phase 1–2 clinical trial, we enrolled patients (1 to 25 years of age) with relapsed or refractory, high-risk neuroblastoma in order to test autologous, third-generation GD2-CAR T cells expressing the inducible caspase 9 suicide gene (GD2-CART01). A total of 27 children with heavily pretreated neuroblastoma (12 with refractory disease, 14 with relapsed disease, and 1 with a complete response at the end of first-line therapy) were enrolled and received GD2-CART01. No failure to generate GD2-CART01 was observed. Three dose levels were tested (3-, 6-, and 10×106 CAR-positive T cells per kilogram of body weight) in the phase 1 portion of the trial, and no dose-limiting toxic effects were recorded; the recommended dose for the phase 2 portion of the trial was 10×106 CAR-positive T cells per kilogram. Cytokine release syndrome occurred in 20 of 27 patients (74%) and was mild in 19 of 20 (95%). In 1 patient, the suicide gene was activated, with rapid elimination of GD2-CART01. GD2-targeted CAR T cells expanded in vivo and were detectable in peripheral blood in 26 of 27 patients up to 30 months after infusion (median persistence, 3 months; range, 1 to 30). Seventeen children had a response to the treatment (overall response, 63%); 9 patients had a complete response, and 8 had a partial response. Among the patients who received the recommended dose, the 3-year overall survival and event-free survival were 60% and 36%, respectively. The use of GD2-CART01 was feasible and safe in treating high-risk neuroblastoma. Treatment-related toxic effects developed, and the activation of the suicide gene controlled side effects. GD2-CART01 may have a sustained antitumor effect. (Funded by the Italian Medicines Agency and others; ClinicalTrials.gov number, NCT03373097.) QUICK TAKE VIDEO SUMMARYGD2-CART01 in Relapsed or Refractory Neuroblastoma 02:12
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Cites
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Chimeric Antigen Receptor Therapy
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Cited by
Sun, Y., Florio, T. J., Gupta, S., Young, M. C., Marshall, Q. F., Garfinkle, S. E., Papadaki, G. F., Truong, H. V., Mycek, E., Li, P., et al. (2023) · Science Immunology · doi:10.1126/sciimmunol.adj5792 · Cited by 19
Metadata
- Authors
- Del Bufalo, F., De Angelis, B., Caruana, I., Del Baldo, G., De Ioris, M. A., Serra, A., Mastronuzzi, A., Cefalo, M. G., Pagliara, D., Amicucci, M., Li Pira, G., Leone, G., Bertaina, V., Sinibaldi, M., Di Cecca, S., Guercio, M., Abbaszadeh, Z., Iaffaldano, L., Gunetti, M., Iacovelli, S., Bugianesi, R., Macchia, S., Algeri, M., Merli, P., Galaverna, F., Abbas, R., Garganese, M. C., Villani, M. F., Colafati, G. S., Bonetti, F., Rabusin, M., Perruccio, K., Folsi, V., Quintarelli, C., & Locatelli, F.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2023-04-06
- Volume
- 388
- Issue
- 14
- Pages
- 1284-1295
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4362636088
- Cited by
- 561
- References
- 31
- FWCI
- 57.98
- Type
- journal article
- Language
- en
- Open access
- closed
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- Del Bufalo, F., De Angelis, B., Caruana, I., Del Baldo, G., De Ioris, M. A., Serra, A., Mastronuzzi, A., Cefalo, M. G., Pagliara, D., Amicucci, M., Li Pira, G., Leone, G., Bertaina, V., Sinibaldi, M., Di Cecca, S., Guercio, M., Abbaszadeh, Z., Iaffaldano, L., Gunetti, M., . . . Locatelli, F. (2023). GD2-CART01 for Relapsed or Refractory High-Risk Neuroblastoma. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2210859
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