{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T02:04:05Z","timestamp":1788919445751,"version":"build-2803163510"},"reference-count":26,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"20","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,7,10]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>\n              Mantle cell lymphoma (MCL) is an aggressive B-cell malignancy characterized by t(11;14) and bright CD20 expression. To improve outcomes from single targeted CD19 chimeric antigen receptor (CAR) T cells, we used dual targeted lentiviral anti-CD20\/anti-CD19 (LV20.19) CAR T cells as part of a phase I\/II clinical trial in relapsed, refractory (R\/R) MCL (ClinicalTrials.gov identifier:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04186520\">NCT04186520<\/jats:ext-link>\n              ).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS<\/jats:title>\n            <jats:p>Patients with MCL who had failed two lines of therapy or relapsed post-transplant were eligible. LV20.19 CAR T cells were manufactured on-site via CliniMACS Prodigy using an adaptive 8- to 12-day process to optimize the final CAR product for increased numbers of na\u00efve and stem-cell memory (SCM) like T cells.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>\n              Seventeen patients with R\/R MCL received a single dose of LV20.19 CAR T cells at 2.5 \u00d7 10\n              <jats:sup>6<\/jats:sup>\n              cells\/kg (phase I = three patients; phase II = 14 patients). The best overall response rate (ORR) was 100% (complete response [CR] = 88%; partial response = 12%) and the phase II efficacy threshold for day-90 CR rate was exceeded. Two patients have relapsed as of the data cutoff and neither the median progression-free survival nor overall survival has been reached with a median follow-up of 15.8 months. Ninety-four percent (n = 16) experienced cytokine release syndrome, all grade 1-2. Eighteen percent (n = 3) had immune effector cell\u2013associated neurotoxicity syndrome in the first 28-days, two with reversible grade 3 toxicity. Three patients had nonrelapse mortality events; all occurred in the setting of ongoing B-cell aplasia. The final LV20.19 CAR products were enriched for higher percentages of T-\n              <jats:sub>SCM<\/jats:sub>\n              \/T-na\u00efve cells and most patients received CAR T cells within 8 days of apheresis.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>In conclusion, we demonstrate that on-site adaptive manufactured LV20.19 CAR T cells are feasible, safe, and efficacious for R\/R MCL with best ORR of 100%, a favorable safety profile, and few relapses to date.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/jco-24-02158","type":"journal-article","created":{"date-parts":[[2025,3,31]],"date-time":"2025-03-31T20:01:47Z","timestamp":1743451307000},"page":"2285-2295","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":16,"title":["Phase I\/II Study of Adaptive Manufactured Lentiviral Anti-CD20\/Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed, Refractory Mantle Cell Lymphoma"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct04186520","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4336-1071","authenticated-orcid":true,"given":"Nirav N.","family":"Shah","sequence":"first","affiliation":[{"name":"BMT &amp; Cellular Therapy Program, Division of Hematology &amp; Oncology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3675-3608","authenticated-orcid":true,"given":"Alfredo S.","family":"Colina","sequence":"additional","affiliation":[{"name":"Department of Microbiology &amp; Immunology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryon D.","family":"Johnson","sequence":"additional","affiliation":[{"name":"BMT &amp; Cellular Therapy Program, Division of Hematology &amp; Oncology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aniko","family":"Szabo","sequence":"additional","affiliation":[{"name":"Division of Biostatistics, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fateeha","family":"Furqan","sequence":"additional","affiliation":[{"name":"BMT &amp; Cellular Therapy Program, Division of Hematology &amp; Oncology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9255-892X","authenticated-orcid":true,"given":"Tyce","family":"Kearl","sequence":"additional","affiliation":[{"name":"BMT &amp; Cellular Therapy Program, Division of Hematology &amp; Oncology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7130-7374","authenticated-orcid":true,"given":"Dina","family":"Schneider","sequence":"additional","affiliation":[{"name":"Lentigen Technology Inc, a Miltenyi Biotec Company, Gaithersburg, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-0834-4347","authenticated-orcid":true,"given":"Marlenny","family":"Vargas-Cortes","sequence":"additional","affiliation":[{"name":"Division of Hematology &amp; Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9800-3144","authenticated-orcid":true,"given":"Jessica L.","family":"Schmeling","sequence":"additional","affiliation":[{"name":"Division of Hematology &amp; Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael B.","family":"Dwinell","sequence":"additional","affiliation":[{"name":"Department of Microbiology &amp; Immunology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Palen","sequence":"additional","affiliation":[{"name":"BMT &amp; Cellular Therapy Program, Division of Hematology &amp; Oncology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Longo","sequence":"additional","affiliation":[{"name":"BMT &amp; Cellular Therapy Program, Division of Hematology &amp; Oncology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5836-4497","authenticated-orcid":true,"given":"Peiman","family":"Hematti","sequence":"additional","affiliation":[{"name":"BMT &amp; Cellular Therapy Program, Division of Hematology &amp; Oncology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5712-5339","authenticated-orcid":true,"given":"Anthony E.","family":"Zamora","sequence":"additional","affiliation":[{"name":"Department of Microbiology &amp; Immunology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8800-297X","authenticated-orcid":true,"given":"Parameswaran","family":"Hari","sequence":"additional","affiliation":[{"name":"BMT &amp; Cellular Therapy Program, Division of Hematology &amp; Oncology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Bucklan","sequence":"additional","affiliation":[{"name":"Department of Radiology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley","family":"Cunningham","sequence":"additional","affiliation":[{"name":"Department of Pathology, Medical College of Wisconsin, Milwaukee, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5372-510X","authenticated-orcid":true,"given":"Mehdi","family":"Hamadani","sequence":"additional","affiliation":[{"name":"BMT &amp; 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