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We generated an advanced therapy medicinal product (ATMP) composed of mature \u03b3\u03b4 T and NK cells to provide an innovative tool to protect patients against tumor relapse and life-threatening infection after haploidentical hematopoietic stem cell transplantation. The ATMP was manufactured and validated in a GMP facility and was obtained from leukapheresis stimulated with zoledronic acid and IL-2, afterward depleted of \u03b1\u03b2 T lymphocytes using the CliniMACS Prodigy. The ATMP is characterized by high homogeneity, cell viability, cytotoxic abilities, stability after cryogenic preservation, and it was virtually free of \u03b1\u03b2 T and B lymphocytes. Both NK and \u03b3\u03b4 T cells were activated and characterized by high expression of cytotoxic and activating receptors including NKG2D, CD16, NKp30, NKp44, and NKp46. Furthermore, \u03b3\u03b4 T lymphocytes and NK cells were cytotoxic against myeloid leukemia or neuroblastoma cells. In conclusion, we implemented a novel ATMP to be shortly translated into clinical practice, which may be used in the post-transplant phase as efficacious immunotherapy in neuroblastoma and leukemic pediatric patients.<\/jats:p>","DOI":"10.1177\/09636897251374248","type":"journal-article","created":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T12:10:02Z","timestamp":1772280602000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["A novel GMP-manufactured medicinal product candidate composed of NK and \u03b3\u03b4 T cells as adjunct immunotherapy for hematopoietic stem cell transplantation"],"prefix":"10.1177","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2849-7595","authenticated-orcid":false,"given":"Fabio","family":"Morandi","sequence":"first","affiliation":[{"name":"UOSD Laboratorio Terapie Cellulari, Dipartimento dei Servizi, IRCCS Istituto Giannina Gaslini, Genova, 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