{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,12]],"date-time":"2026-11-12T12:50:56Z","timestamp":1794487856809,"version":"4.9.1"},"reference-count":26,"publisher":"American Society of Hematology","issue":"10","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,9,4]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>Relapsed\/refractory T-cell acute lymphoblastic leukemia (ALL; T-ALL)\/lymphoma (LBL) represent a significant unmet medical need. WU-CART-007 is a CD7-targeting, allogeneic, fratricide-resistant chimeric antigen receptor T-cell product generated from healthy donor T cells. WU-CART-007 was evaluated in a phase 1\/2 study with a 3+3 dose-escalation design followed by cohort expansion in relapsed\/refractory T-ALL\/LBL. Patients received 1 infusion of WU-CART-007 after standard or enhanced lymphodepleting chemotherapy. The primary objectives, to characterize safety and assess the composite complete remission rate, were met. Of 28 patients enrolled, 13 received the recommended phase 2 dose (RP2D) of 900 \u00d7 106 cells of WU-CART-007 with enhanced lymphodepletion. The most common treatment-related adverse event was cytokine release syndrome (88.5%; 19.2% grade 3-4). Two grade 1 immune effector cell\u2013associated neurotoxicity syndrome events (7.7%) and 1 grade 2 acute graft-versus-host disease event occurred (3.8%). One grade 2 immune effector cell\u2013associated hemophagocytic lymphohistiocytosis\u2013like syndrome was observed. Among the 11 patients evaluable for response at the RP2D who received enhanced lymphodepleting chemotherapy, the overall response rate was 90.9%, and the composite complete remission rate was 72.7%. WU-CART-007 at the RP2D demonstrated a high response rate in patients with relapsed\/refractory T-ALL\/LBL and has the potential to provide a new treatment option. This trial was registered at www.ClinicalTrials.gov as #NCT04984356.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2025028387","type":"journal-article","created":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T12:45:36Z","timestamp":1748609136000},"page":"1163-1173","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":37,"title":["Phase 1\/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed\/refractory T-cell malignancies"],"prefix":"10.1182","volume":"146","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8848-8474","authenticated-orcid":false,"given":"Armin","family":"Ghobadi","sequence":"first","affiliation":[{"name":"1Washington University School of Medicine, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahim","family":"Aldoss","sequence":"additional","affiliation":[{"name":"2City of Hope, Duarte, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon L.","family":"Maude","sequence":"additional","affiliation":[{"name":"3Children\u2019s Hospital of Philadelphia, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepa","family":"Bhojwani","sequence":"additional","affiliation":[{"name":"4Children\u2019s Hospital Los Angeles, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan S.","family":"Wayne","sequence":"additional","affiliation":[{"name":"4Children\u2019s Hospital Los Angeles, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish","family":"Bajel","sequence":"additional","affiliation":[{"name":"5Peter MacCallum Cancer Center and The Royal Melbourne Hospital, Melbourne, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2371-3655","authenticated-orcid":false,"given":"Bhagirathbhai","family":"Dholaria","sequence":"additional","affiliation":[{"name":"6Vanderbilt University Medical Center, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rawan","family":"Faramand","sequence":"additional","affiliation":[{"name":"7Moffitt Cancer Center, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan J.","family":"Mattison","sequence":"additional","affiliation":[{"name":"8University of Wisconsin Carbone Cancer Center, Madison, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Rijneveld","sequence":"additional","affiliation":[{"name":"9Erasmus Medical Center Cancer Institute, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. Michel","family":"Zwaan","sequence":"additional","affiliation":[{"name":"10Prinses M\u00e1xima Centrum, Utrecht, The Netherlands"},{"name":"11Sophia Children\u2019s Hospital, Erasmus MC, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9059-0929","authenticated-orcid":false,"given":"Friso","family":"Calkoen","sequence":"additional","affiliation":[{"name":"10Prinses M\u00e1xima Centrum, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andre","family":"Baruchel","sequence":"additional","affiliation":[{"name":"12Robert Debr\u00e9 University Hospital, Assistance Publique\u2013H\u00f4pitaux de Paris, Universit\u00e9 Paris Cit\u00e9, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2091-7927","authenticated-orcid":false,"given":"Nicolas","family":"Boissel","sequence":"additional","affiliation":[{"name":"13Saint-Louis Hospital, Universit\u00e9 Paris Diderot, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1091-0564","authenticated-orcid":false,"given":"Michael","family":"Rettig","sequence":"additional","affiliation":[{"name":"1Washington University School of Medicine, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent","family":"Wood","sequence":"additional","affiliation":[{"name":"4Children\u2019s Hospital Los Angeles, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Jacobs","sequence":"additional","affiliation":[{"name":"14Mersana Therapeutics, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Christ","sequence":"additional","affiliation":[{"name":"1Washington University School of Medicine, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haley","family":"Irons","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Capoccia","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Masters","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justo","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tony","family":"Wu","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria del","family":"Rosario","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6027-1350","authenticated-orcid":false,"given":"Alexander","family":"Hamil","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ouiam","family":"Bakkacha","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Muth","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brett","family":"Ramsey","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eileen","family":"McNulty","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Baughman","sequence":"additional","affiliation":[{"name":"16Alviso Clinical Research, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2395-8628","authenticated-orcid":false,"given":"Matthew L.","family":"Cooper","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Davidson-Moncada","sequence":"additional","affiliation":[{"name":"15Wugen, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John F.","family":"DiPersio","sequence":"additional","affiliation":[{"name":"1Washington University School of Medicine, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"234","reference":[{"issue":"9","key":"2025092310465647700_bib1","doi-asserted-by":"crossref","first-page":"E245","DOI":"10.1002\/ajh.25896","article-title":"Outcome of adults with relapsed\/refractory T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma","volume":"95","author":"Samra","year":"2020","journal-title":"Am J Hematol"},{"issue":"12","key":"2025092310465647700_bib2","doi-asserted-by":"crossref","first-page":"792","DOI":"10.1007\/s00277-005-1090-9","article-title":"FLAG-IDA in the treatment of refractory\/relapsed adult acute lymphoblastic leukemia","volume":"84","author":"Specchia","year":"2005","journal-title":"Ann Hematol"},{"issue":"6","key":"2025092310465647700_bib3","doi-asserted-by":"crossref","first-page":"1158","DOI":"10.1111\/bjh.15793","article-title":"Lymphoblastic lymphoma in children and adolescents: review of current challenges and future opportunities","volume":"185","author":"Burkhardt","year":"2019","journal-title":"Br J Haematol"},{"issue":"4","key":"2025092310465647700_bib4","doi-asserted-by":"crossref","first-page":"454","DOI":"10.1111\/bjh.12042","article-title":"The immunophenotype of T-lymphoblastic lymphoma in children and adolescents: a Children\u2019s Oncology Group report","volume":"159","author":"Patel","year":"2012","journal-title":"Br J Haematol"},{"issue":"14","key":"2025092310465647700_bib5","doi-asserted-by":"crossref","first-page":"3466","DOI":"10.1182\/bloodadvances.2020001822","article-title":"T-cell lymphoblastic lymphoma and leukemia: different diseases from a common premalignant progenitor?","volume":"4","author":"Kroeze","year":"2020","journal-title":"Blood Adv"},{"issue":"12","key":"2025092310465647700_bib6","doi-asserted-by":"crossref","first-page":"1063","DOI":"10.1002\/gcc.20924","article-title":"T-cell lymphoblastic lymphoma shows differences and similarities with T-cell acute lymphoblastic leukemia by genomic and gene expression analyses","volume":"50","author":"Basso","year":"2011","journal-title":"Genes Chromosomes Cancer"},{"issue":"20","key":"2025092310465647700_bib7","doi-asserted-by":"crossref","first-page":"2391","DOI":"10.1182\/blood-2016-03-643544","article-title":"The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia","volume":"127","author":"Arber","year":"2016","journal-title":"Blood"},{"issue":"7","key":"2025092310465647700_bib8","doi-asserted-by":"crossref","first-page":"833","DOI":"10.1182\/blood-2014-10-551895","article-title":"How I treat T-cell acute lymphoblastic leukemia in adults","volume":"126","author":"Litzow","year":"2015","journal-title":"Blood"},{"issue":"9","key":"2025092310465647700_bib9","doi-asserted-by":"crossref","first-page":"1134","DOI":"10.1182\/blood-2016-07-692608","article-title":"Management of adults with T-cell lymphoblastic leukemia [published correction information appears in Blood. 2017;129(15):2204]","volume":"129","author":"Marks","year":"2017","journal-title":"Blood"},{"issue":"3","key":"2025092310465647700_bib10","doi-asserted-by":"crossref","first-page":"944","DOI":"10.1182\/blood-2006-05-018192","article-title":"Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12\/ECOG 2993 study","volume":"109","author":"Fielding","year":"2007","journal-title":"Blood"},{"issue":"6","key":"2025092310465647700_bib11","doi-asserted-by":"crossref","first-page":"709","DOI":"10.1634\/theoncologist.2006-0017","article-title":"FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia\/lymphoma","volume":"13","author":"Cohen","year":"2008","journal-title":"Oncologist"},{"issue":"4","key":"2025092310465647700_bib12","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1093\/ajcp\/111.4.467","article-title":"Acute lymphoblastic leukemia. Survey of immunophenotype, French-American-British classification, frequency of myeloid antigen expression, and karyotypic abnormalities in 210 pediatric and adult cases","volume":"111","author":"Khalidi","year":"1999","journal-title":"Am J Clin Pathol"},{"key":"2025092310465647700_bib13","author":"Food and Drug Administration (FDA)","year":"2017"},{"issue":"9","key":"2025092310465647700_bib14","doi-asserted-by":"crossref","first-page":"1970","DOI":"10.1038\/s41375-018-0065-5","article-title":"An \u201coff-the-shelf\u201d fratricide-resistant CAR-T for the treatment of T cell hematologic malignancies","volume":"32","author":"Cooper","year":"2018","journal-title":"Leukemia"},{"issue":"10","key":"2025092310465647700_bib15","doi-asserted-by":"crossref","first-page":"899","DOI":"10.1056\/NEJMoa2300709","article-title":"Base-edited CAR7 T cells for relapsed T-cell acute lymphoblastic leukemia","volume":"389","author":"Chiesa","year":"2023","journal-title":"N Engl J Med"},{"issue":"11","key":"2025092310465647700_bib16","doi-asserted-by":"crossref","first-page":"2176","DOI":"10.1038\/s41375-023-02018-4","article-title":"CD7 targeted \u201coff-the-shelf\u201d CAR-T demonstrates robust in vivo expansion and high efficacy in the treatment of patients with relapsed and refractory T cell malignancies","volume":"37","author":"Li","year":"2023","journal-title":"Leukemia"},{"issue":"4","key":"2025092310465647700_bib17","first-page":"321","article-title":"Naturally selected CD7 CAR-T therapy without genetic manipulations for T-ALL\/LBL: first-in-human phase 1 clinical trial","volume":"140","author":"Lu","year":"2022","journal-title":"Blood"},{"issue":"30","key":"2025092310465647700_bib18","doi-asserted-by":"crossref","first-page":"3340","DOI":"10.1200\/JCO.21.00389","article-title":"Donor-derived CD7 chimeric antigen receptor T cells for T-cell acute lymphoblastic leukemia: first-in-human, phase I trial","volume":"39","author":"Pan","year":"2021","journal-title":"J Clin Oncol"},{"issue":"16","key":"2025092310465647700_bib19","doi-asserted-by":"crossref","first-page":"1467","DOI":"10.1056\/NEJMoa2313812","article-title":"Sequential CD7 CAR T-cell therapy and allogeneic HSCT without GVHD prophylaxis","volume":"390","author":"Hu","year":"2024","journal-title":"N Engl J Med"},{"issue":"5","key":"2025092310465647700_bib20","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1056\/NEJMoa1709866","article-title":"Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia","volume":"378","author":"Maude","year":"2018","journal-title":"N Engl J Med"},{"issue":"27","key":"2025092310465647700_bib21","doi-asserted-by":"crossref","first-page":"3059","DOI":"10.1200\/JCO.2013.54.8800","article-title":"Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification","volume":"32","author":"Cheson","year":"2014","journal-title":"J Clin Oncol"},{"issue":"4","key":"2025092310465647700_bib22","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1016\/j.bbmt.2018.12.758","article-title":"ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells","volume":"25","author":"Lee","year":"2019","journal-title":"Biol Blood Marrow Transpl"},{"issue":"7","key":"2025092310465647700_bib23","doi-asserted-by":"crossref","first-page":"438.e1","DOI":"10.1016\/j.jtct.2023.03.006","article-title":"Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome","volume":"29","author":"Hines","year":"2023","journal-title":"Transpl Cell Ther"},{"key":"2025092310465647700_bib24","author":"U.S. Department of Health and Human Services","year":"2017"},{"issue":"12","key":"2025092310465647700_bib25","doi-asserted-by":"crossref","first-page":"2154","DOI":"10.1016\/j.bbmt.2015.08.023","article-title":"Transplant outcomes for children with T cell acute lymphoblastic leukemia in second remission: a report from the Center for International Blood and Marrow Transplant Research","volume":"21","author":"Burke","year":"2015","journal-title":"Biol Blood Marrow Transpl"},{"issue":"12","key":"2025092310465647700_bib26","doi-asserted-by":"crossref","first-page":"3687","DOI":"10.1038\/s41591-024-03228-8","article-title":"Fratricide-resistant CD7-CAR T cells in T-ALL","volume":"30","author":"Oh","year":"2024","journal-title":"Nat Med"}],"container-title":["Blood"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ashpublications.org\/blood\/article-pdf\/146\/10\/1163\/2411070\/blood_bld-2025-028387-main.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/ashpublications.org\/blood\/article-pdf\/146\/10\/1163\/2411070\/blood_bld-2025-028387-main.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,23]],"date-time":"2025-09-23T14:47:08Z","timestamp":1758638828000},"score":1,"resource":{"primary":{"URL":"https:\/\/ashpublications.org\/blood\/article\/146\/10\/1163\/537566\/Phase-1-2-trial-of-anti-CD7-allogeneic-WU-CART-007"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,4]]},"references-count":26,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2025,9,4]]}},"URL":"https:\/\/doi.org\/10.1182\/blood.2025028387","relation":{},"ISSN":["0006-4971","1528-0020"],"issn-type":[{"value":"0006-4971","type":"print"},{"value":"1528-0020","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,9,4]]},"published":{"date-parts":[[2025,9,4]]}}}