{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T20:27:11Z","timestamp":1783628831013,"version":"3.55.0"},"reference-count":31,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"7","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Glob Oncol"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Industry-driven chimeric antigen receptor (CAR)-T cell manufacturing is complex and time-consuming. We hypothesized that decentralized manufacturing of CAR-T cells on an automated closed CliniMACS Prodigy system (Miltenyi Biotec) is feasible and reproducible for patients with relapsed refractory non-Hodgkin's lymphoma (rrNHL) in a developing country.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>MATERIALS AND METHODS<\/jats:title>\n                    <jats:p>To manufacture anti\u2013MB-19.1-CAR-T cell products, peripheral blood mononuclear cells were collected, enriched into pure T cells by positive selection using CD4 and CD8 magnetic beads, redirected into the chamber of the CliniMACS Prodigy for activation with the T-cell TransAct reagent containing CD3 and CD28, followed by transduction by anti\u2013MB-CD19.1-CAR Lentiviral Vector, and cultured for 12 days followed by cell harvesting. Eleven products were manufactured, three from healthy donors for feasibility evaluation and eight clinical-grade products under a phase II clinical trial. Quality control and release manufacturer standards were set to ensure their identity, viability, purity, sterility, and potency.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Eleven anti\u2013CD19.1-CAR-T products with reproducible key characteristics were manufactured. Validation run data demonstrated a successful anti\u2013CD19.1-CAR-T cell production with 51-fold T-cell expansion, a robust transduction efficiency of 26%, a viability of 98%, and fulfillment of manufacturer standards for clinical application. Clinical-grade products demonstrated 35-fold T-cell expansion, 44% transduction efficiency, and 99.8% viability, and fulfilling quality checks. The average vein-to-vein time is 15.25 days (range, 15-17). Safety and efficacy of clinical-grade products in the first eight patients enrolled showed reasonable objective responses with no new safety signals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Our data highlight the feasibility and reproducibility of the point of care of anti\u2013CD19.1-CAR-T cells in a developing country, Jordan.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/go-25-00648","type":"journal-article","created":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T19:59:11Z","timestamp":1783627151000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":0,"title":["Point-of-Care Manufacturing of Anti\u2013CD19.1-Chimeric Antigen Receptor-T Cells Using CliniMACS Prodigy: Real-World Experience From Jordan"],"prefix":"10.1200","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1161-9138","authenticated-orcid":true,"given":"Khalid","family":"Halahleh","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Adult Bone Marrow Transplantation and Cellular Therapy Program, King Hussein Cancer Center, Amman, Jordan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad","family":"Abu-Khader","sequence":"additional","affiliation":[{"name":"Department of Cell Therapy and Applied Genomics, King Hussein Cancer Center, Amman, Jordan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-7190-9460","authenticated-orcid":true,"given":"Husam","family":"Abu-Jazar","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Adult Bone Marrow Transplantation and Cellular Therapy Program, King Hussein Cancer Center, Amman, 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