{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T13:44:18Z","timestamp":1793281458960,"version":"4.5.0"},"reference-count":51,"publisher":"American Society of Hematology","issue":"21","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,11,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>T cells expressing CD19-specific chimeric antigen receptors (CD19-CARs) have potent antileukemia activity in pediatric and adult patients with relapsed and\/or refractory B-cell acute lymphoblastic leukemia (B-ALL). However, not all patients achieve a complete response (CR), and a significant percentage relapse after CD19-CAR T-cell therapy due to T-cell intrinsic and\/or extrinsic mechanisms. Thus, there is a need to evaluate new CD19-CAR T-cell products in patients to improve efficacy. We developed a phase 1\/2 clinical study to evaluate an institutional autologous CD19-CAR T-cell product in pediatric patients with relapsed\/refractory B-ALL. Here we report the outcome of the phase 1 study participants (n\u00a0= 12). Treatment was well tolerated, with a low incidence of both cytokine release syndrome (any grade, n\u00a0= 6) and neurotoxicity (any grade, n\u00a0= 3). Nine out of 12 patients (75%) achieved a minimal residual disease-negative CR in the bone marrow (BM). High disease burden (\u226540% morphologic blasts) before CAR T-cell infusion correlated with increased side effects and lower response rate, but not with CD19-CAR T-cell expansion. After infusion, CD8+ CAR T cells had a proliferative advantage over CD4+ CAR T cells and at peak expansion, had an effector memory phenotype with evidence of antigen-driven differentiation. Patients that proceeded to allogeneic hematopoietic cell transplantation (AlloHCT) had sustained, durable responses. In summary, the initial evaluation of our institutional CD19-CAR T-cell product demonstrates safety and efficacy while highlighting the impact of pre-infusion disease burden on outcomes. This trial was registered at www.clinicaltrials.gov as #NCT03573700.<\/jats:p>","DOI":"10.1182\/bloodadvances.2021006293","type":"journal-article","created":{"date-parts":[[2022,4,21]],"date-time":"2022-04-21T14:02:39Z","timestamp":1650549759000},"page":"5737-5749","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":65,"title":["Preferential expansion of CD8+ CD19-CAR T cells postinfusion and the role of disease burden on outcome in pediatric B-ALL"],"prefix":"10.1182","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6558-6706","authenticated-orcid":false,"given":"Aimee C.","family":"Talleur","sequence":"first","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amr","family":"Qudeimat","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9627-3104","authenticated-orcid":false,"given":"Jean-Yves","family":"M\u00e9tais","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deanna","family":"Langfitt","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ewelina","family":"Mamcarz","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4096-6048","authenticated-orcid":false,"given":"Jeremy Chase","family":"Crawford","sequence":"additional","affiliation":[{"name":"2Department of Immunology, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sujuan","family":"Huang","sequence":"additional","affiliation":[{"name":"3Department of Biostatistics, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng","family":"Cheng","sequence":"additional","affiliation":[{"name":"3Department of Biostatistics, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caitlin","family":"Hurley","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renee","family":"Madden","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3281-2081","authenticated-orcid":false,"given":"Akshay","family":"Sharma","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Suliman","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashok","family":"Srinivasan","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1533-7234","authenticated-orcid":false,"given":"M. Paulina","family":"Velasquez","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8691-7439","authenticated-orcid":false,"given":"Esther A.","family":"Obeng","sequence":"additional","affiliation":[{"name":"4Department of Oncology, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Willis","sequence":"additional","affiliation":[{"name":"5Therapeutics Production and Quality, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salem","family":"Akel","sequence":"additional","affiliation":[{"name":"6Human Applications Laboratory, St. Jude Children\u2019s Research Hospital, Memphis, 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Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2583-2092","authenticated-orcid":false,"given":"Sagar L","family":"Patil","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Li","sequence":"additional","affiliation":[{"name":"1Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7955-0256","authenticated-orcid":false,"given":"Paul G.","family":"Thomas","sequence":"additional","affiliation":[{"name":"2Department of Immunology, St. Jude Children\u2019s Research Hospital, Memphis, 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