{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T02:46:35Z","timestamp":1793414795534,"version":"4.5.0"},"reference-count":25,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"10","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,4,1]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>To report the primary analysis results from the mantle cell lymphoma (MCL) cohort of the phase I seamless design TRANSCEND NHL 001 (ClinicalTrials.gov identifier: NCT02631044 ) study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      Patients with relapsed\/refractory (R\/R) MCL after \u2265two lines of previous therapy, including a Bruton tyrosine kinase inhibitor (BTKi), an alkylating agent, and a CD20-targeted agent, received lisocabtagene maraleucel (liso-cel) at a target dose level (DL) of 50 \u00d7 10\n                      <jats:sup>6<\/jats:sup>\n                      (DL1) or 100 \u00d7 10\n                      <jats:sup>6<\/jats:sup>\n                      (DL2) chimeric antigen receptor-positive T cells. Primary end points were adverse events (AEs), dose-limiting toxicities, and objective response rate (ORR) by independent review committee per Lugano criteria.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Of 104 leukapheresed patients, liso-cel was infused into 88. Median (range) number of previous lines of therapy was three (1-11) with 30% receiving \u2265five previous lines of therapy, 73% of patients were age 65 years and older, 69% had refractory disease, 53% had BTKi refractory disease, 23% had TP53 mutation, and 8% had secondary CNS lymphoma. Median (range) on-study follow-up was 16.1 months (0.4-60.5). In the efficacy set (n = 83; DL1 + DL2), ORR was 83.1% (95% CI, 73.3 to 90.5) and complete response (CR) rate was 72.3% (95% CI, 61.4 to 81.6). Median duration of response was 15.7 months (95% CI, 6.2 to 24.0) and progression-free survival was 15.3 months (95% CI, 6.6 to 24.9). Most common grade \u22653 treatment-emergent AEs were neutropenia (56%), anemia (37.5%), and thrombocytopenia (25%). Cytokine release syndrome (CRS) was reported in 61% of patients (grade 3\/4, 1%; grade 5, 0), neurologic events (NEs) in 31% (grade 3\/4, 9%; grade 5, 0), grade \u22653 infections in 15%, and prolonged cytopenia in 40%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Liso-cel demonstrated high CR rate and deep, durable responses with low incidence of grade \u22653 CRS, NE, and infections in patients with heavily pretreated R\/R MCL, including those with high-risk, aggressive disease.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.23.02214","type":"journal-article","created":{"date-parts":[[2023,12,10]],"date-time":"2023-12-10T21:10:12Z","timestamp":1702242612000},"page":"1146-1157","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":116,"title":["Lisocabtagene Maraleucel in Relapsed\/Refractory Mantle Cell Lymphoma: Primary Analysis of the Mantle Cell Lymphoma Cohort From TRANSCEND NHL 001, a Phase I Multicenter Seamless Design Study"],"prefix":"10.1200","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct02631044","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9748-5486","authenticated-orcid":false,"given":"Michael","family":"Wang","sequence":"first","affiliation":[{"name":"The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5292-8298","authenticated-orcid":false,"given":"Tanya","family":"Siddiqi","sequence":"additional","affiliation":[{"name":"City of Hope National Medical Center, Duarte, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1666-7064","authenticated-orcid":false,"given":"Leo I.","family":"Gordon","sequence":"additional","affiliation":[{"name":"Northwestern University, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manali","family":"Kamdar","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center, Aurora, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Lunning","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center, Omaha, NE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7980-3882","authenticated-orcid":false,"given":"Alexandre V.","family":"Hirayama","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8467-9257","authenticated-orcid":false,"given":"Jeremy S.","family":"Abramson","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon","family":"Arnason","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nilanjan","family":"Ghosh","sequence":"additional","affiliation":[{"name":"Atrium Health, Levine Cancer Institute, Charlotte, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amitkumar","family":"Mehta","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, AL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charalambos","family":"Andreadis","sequence":"additional","affiliation":[{"name":"University of California, San Francisco, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2061-8126","authenticated-orcid":false,"given":"Scott R.","family":"Solomon","sequence":"additional","affiliation":[{"name":"Northside Hospital Cancer Institute, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Kostic","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Dehner","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo","family":"Espinola","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lily","family":"Peng","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4264-8927","authenticated-orcid":false,"given":"Ken","family":"Ogasawara","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-1099-1678","authenticated-orcid":false,"given":"Amy","family":"Chattin","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurie","family":"Eliason","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5099-9156","authenticated-orcid":false,"given":"M. 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