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Development of a Safety Surveillance Plan for the Academic Medicine Sponsor Performing First-in-Human Cellular Therapy Clinical Trials: A Report from the Consortium for Pediatric Cellular Immunotherapy.
Adams C, Keller M, Michlitsch JG, Aguayo-Hiraldo P, Chen K, Hossain MZ, Davis A, Park JR, Verneris MR, Gardner RA. Adams C, et al. Among authors: gardner ra. Transplant Cell Ther. 2024 May;30(5):475-487. doi: 10.1016/j.jtct.2024.02.022. Epub 2024 Mar 4. Transplant Cell Ther. 2024. PMID: 38447751 Review.
Modified Manufacturing Process Modulates CD19CAR T-cell Engraftment Fitness and Leukemia-Free Survival in Pediatric and Young Adult Subjects.
Ceppi F, Wilson AL, Annesley C, Kimmerly GR, Summers C, Brand A, Seidel K, Wu QV, Beebe A, Brown C, Mgebroff S, Lindgren C, Rawlings-Rhea SD, Huang W, Pulsipher MA, Wayne AS, Park JR, Jensen MC, Gardner RA. Ceppi F, et al. Among authors: gardner ra. Cancer Immunol Res. 2022 Jul 1;10(7):856-870. doi: 10.1158/2326-6066.CIR-21-0501. Cancer Immunol Res. 2022. PMID: 35580141 Free PMC article. Clinical Trial.
Paving the Road for Chimeric Antigen Receptor T Cells: American Society for Transplantation and Cellular Therapy 80/20 Task Force Consensus on Challenges and Solutions to Improving Efficiency of Clinical Center Certification and Maintenance of Operations for Commercially Approved Immune Effector Cell Therapies.
Nikiforow S, Frigault MJ, Frey NV, Gardner RA, Komanduri KV, Perales MA, Kebriaei P, Warkentin PI, Pasquini M, Aho JL, Levine BL, Heslop HE, Hlucky TL, Habucky K, Gharibo M, Jagasia M, Locke FL. Nikiforow S, et al. Among authors: gardner ra. Transplant Cell Ther. 2023 Apr;29(4):228-239. doi: 10.1016/j.jtct.2023.01.021. Epub 2023 Jan 26. Transplant Cell Ther. 2023. PMID: 36709800 Free article.
ACT To Sustain: Adoptive Cell Therapy To Sustain access to non-commercialized genetically modified cell therapies.
Gardner RA, White C, Elsallab M, Farnia S, Fraint E, Grilley B, Bateman-House A, Grupp SA, Kenderian S, Locke FL, Nikiforow S, Oluwole OO, Rouce RH, Spiegel J, Shah NN, Sharma A, Komanduri K, Gill S. Gardner RA, et al. Transplant Cell Ther. 2024 May 16:S2666-6367(24)00407-X. doi: 10.1016/j.jtct.2024.05.010. Online ahead of print. Transplant Cell Ther. 2024. PMID: 38762057 Review.
Intraventricular B7-H3 CAR T Cells for Diffuse Intrinsic Pontine Glioma: Preliminary First-in-Human Bioactivity and Safety.
Vitanza NA, Wilson AL, Huang W, Seidel K, Brown C, Gustafson JA, Yokoyama JK, Johnson AJ, Baxter BA, Koning RW, Reid AN, Meechan M, Biery MC, Myers C, Rawlings-Rhea SD, Albert CM, Browd SR, Hauptman JS, Lee A, Ojemann JG, Berens ME, Dun MD, Foster JB, Crotty EE, Leary SES, Cole BL, Perez FA, Wright JN, Orentas RJ, Chour T, Newell EW, Whiteaker JR, Zhao L, Paulovich AG, Pinto N, Gust J, Gardner RA, Jensen MC, Park JR. Vitanza NA, et al. Among authors: gardner ra. Cancer Discov. 2023 Jan 9;13(1):114-131. doi: 10.1158/2159-8290.CD-22-0750. Cancer Discov. 2023. PMID: 36259971 Free PMC article.
A phase I study of panobinostat in children with relapsed and refractory hematologic malignancies.
Goldberg J, Sulis ML, Bender J, Jeha S, Gardner R, Pollard J, Aquino V, Laetsch T, Winick N, Fu C, Marcus L, Sun W, Verma A, Burke M, Ho P, Manley T, Mody R, Tcheng W, Thomson B, Park J, Sposto R, Messinger Y, Hijiya N, Gaynon P, Barredo J. Goldberg J, et al. Pediatr Hematol Oncol. 2020 Sep;37(6):465-474. doi: 10.1080/08880018.2020.1752869. Epub 2020 Apr 27. Pediatr Hematol Oncol. 2020. PMID: 32338562 Clinical Trial.
Anti-HLA antibodies in recipients of CD19 versus BCMA-targeted CAR T-cell therapy.
Hill JA, Kiem ES, Bhatti A, Liu W, Keane-Candib J, Fitzpatrick KS, Boonyaratanakornkit J, Gardner RA, Green DJ, Maloney DG, Turtle CJ, Smith JM, Gimferrer I, Blosser CD, Jackson SW. Hill JA, et al. Among authors: gardner ra. Am J Transplant. 2023 Mar;23(3):416-422. doi: 10.1016/j.ajt.2022.11.001. Epub 2023 Jan 12. Am J Transplant. 2023. PMID: 36748802 Free PMC article.
183 results