{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T01:03:09Z","timestamp":1791507789259,"version":"4.3.4"},"reference-count":38,"publisher":"American Society of Hematology","issue":"8","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,2,22]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>CD19-directed chimeric antigen receptor T cells (CAR-T) achieve high response rates in patients with relapsed\/refractory mantle cell lymphoma (MCL). However, their use is associated with significant toxicity, relapse concern, and unclear broad tractability. Preclinical and clinical data support a beneficial synergistic effect of ibrutinib on apheresis product fitness, CAR-T expansion, and toxicity. We evaluated the combination of time-limited ibrutinib and CTL019 CAR-T in 20 patients with MCL in the phase 2 TARMAC study. Ibrutinib commenced before leukapheresis and continued through CAR-T manufacture for a minimum of 6 months after CAR-T administration. The median prior lines of therapy was 2; 50% of patients were previously exposed to a Bruton tyrosine kinase inhibitor (BTKi). The primary end point was 4-month postinfusion complete response (CR) rate, and secondary end points included safety and subgroup analysis based on TP53 aberrancy. The primary end point was met; 80% of patients demonstrated CR, with 70% and 40% demonstrating measurable residual disease negativity by flow cytometry and molecular methods, respectively. At 13-month median follow-up, the estimated 12-month progression-free survival was 75% and overall survival 100%. Fifteen patients (75%) developed cytokine release syndrome; 12 (55%) with grade 1 to 2 and 3 (20%) with grade 3. Reversible grade 1 to 2 neurotoxicity was observed in 2 patients (10%). Efficacy was preserved irrespective of prior BTKi exposure or TP53 mutation. Deep responses correlated with robust CAR-T expansion and a less exhausted baseline T-cell phenotype. Overall, the safety and efficacy of the combination of BTKi and T-cell redirecting immunotherapy appears promising and merits further exploration. This trial was registered at www.ClinicalTrials.gov as #NCT04234061.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2023021306","type":"journal-article","created":{"date-parts":[[2023,10,26]],"date-time":"2023-10-26T17:31:09Z","timestamp":1698341469000},"page":"673-684","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":86,"title":["CAR T cells and time-limited ibrutinib as treatment for relapsed\/refractory mantle cell lymphoma: the phase 2 TARMAC study"],"prefix":"10.1182","volume":"143","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7357-2024","authenticated-orcid":false,"given":"Adrian","family":"Minson","sequence":"first","affiliation":[{"name":"1Clinical Haematology, Peter MacCallum Cancer Centre, Melbourne, Australia"},{"name":"2Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Australia"},{"name":"3Clinical Haematology, Royal Melbourne Hospital, Melbourne, 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