{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T09:20:13Z","timestamp":1785403213848,"version":"3.56.0"},"reference-count":73,"publisher":"BMJ","issue":"5","funder":[{"name":"National Center of Tumor Diseases"},{"DOI":"10.13039\/100008658","name":"German Cancer Research Institute","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100008658","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Jochen Siebeneicher Foundation"},{"name":"Dr. h.c. Karl Schlecht"},{"name":"Ministry for Science, Research and Arts of Baden-W\u00fcrttemberg \"Br\u00fcckeninstitutionen - Initiative\u201c"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,3,20]]},"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Chimeric antigen receptor (CAR) T cells spark hope for patients with CD19+ B\u2009cell neoplasia, including relapsed or refractory (r\/r) acute lymphoblastic leukaemia (ALL) or r\/r non-Hodgkin\u2019s lymphoma (NHL). Published studies have mostly used second-generation CARs with 4-1BB or CD28 as costimulatory domains. Preclinical results of third-generation CARs incorporating both elements have shown superiority concerning longevity and proliferation. The University Hospital of Heidelberg is the first institution to run an investigator-initiated trial (IIT) CAR T cell trial (Heidelberg Chimeric Antigen Receptor T cell Trial number 1 [HD-CAR-1]) in Germany with third-generation CD19-directed CAR T cells.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      Adult patients with r\/r ALL (stratum I), r\/r NHL including chronic lymphocytic leukaemia, diffuse large B-cell lymphoma, follicular lymphoma or mantle cell lymphoma (stratum II) as well as paediatric patients with r\/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by third-generation RV-SFG.CD19.CD28.4-1BB zeta retroviral vector (CD19.CAR T cells). The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (1\u201320\u00d710\n                      <jats:sup>6<\/jats:sup>\n                      transduced cells\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) after lymphodepletion with fludarabine (flu) and cyclophosphamide (cyc). Patients will be monitored for cytokine release syndrome (CRS), neurotoxicity, i.e. CAR-T-cell-related encephalopathy syndrome (CRES) and\/or other toxicities (primary objectives). Secondary objectives include evaluation of\n                      <jats:italic>in vivo<\/jats:italic>\n                      function and survival of CD19.CAR T cells and assessment of CD19.CAR T cell antitumour efficacy.\n                    <\/jats:p>\n                    <jats:p>HD-CAR-1 as a prospective, monocentric trial aims to make CAR T cell therapy accessible to patients in Europe. Currently, HD-CAR-1 is the first and only CAR T cell IIT in Germany. A third-generation Good Manufacturing Practice (GMP) grade retroviral vector, a broad spectrum of NHL, treatment of paediatric and adult ALL patients and inclusion of patients even after allogeneic stem cell transplantation (alloSCT) make this trial unique.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval and approvals from the local and federal competent authorities were granted. Trial results will be reported via peer-reviewed journals and presented at conferences and scientific meetings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      Eudra CT 2016-004808-60;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03676504\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\">NCT03676504<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-026644","type":"journal-article","created":{"date-parts":[[2019,5,20]],"date-time":"2019-05-20T05:46:12Z","timestamp":1558331172000},"page":"e026644","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":34,"title":["Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector: a unicentre phase I\/II clinical trial protocol"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03676504","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct03676504","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02445222","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02348216","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03484702","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02445248","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Maria-Luisa","family":"Schubert","sequence":"first","affiliation":[{"name":"Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, 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