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We developed and conducted a first-in-human, phase I study of regionally delivered, autologous, mesothelin-targeted chimeric antigen receptor (CAR) T-cell therapy. Intrapleural administration of 0.3M to 60M CAR T cells\/kg in 27 patients (25 with MPM) was safe and well tolerated. CAR T cells were detected in peripheral blood for &amp;gt;100 days in 39% of patients. Following our demonstration that PD-1 blockade enhances CAR T-cell function in mice, 18 patients with MPM also received pembrolizumab safely. Among those patients, median overall survival from CAR T-cell infusion was 23.9 months (1-year overall survival, 83%). Stable disease was sustained for \u22656 months in 8 patients; 2 exhibited complete metabolic response on PET scan. Combination immunotherapy with CAR T cells and PD-1 blockade agents should be further evaluated in patients with solid tumors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance:<\/jats:title>\n                    <jats:p>Regional delivery of mesothelin-targeted CAR T-cell therapy followed by pembrolizumab administration is feasible, safe, and demonstrates evidence of antitumor efficacy in patients with malignant pleural diseases. Our data support the investigation of combination immunotherapy with CAR T cells and PD-1 blockade agents in solid tumors.<\/jats:p>\n                    <jats:p>See related commentary by Aldea et al., p. 2674.<\/jats:p>\n                    <jats:p>This article is highlighted in the In This Issue feature, p. 2659<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1158\/2159-8290.cd-21-0407","type":"journal-article","created":{"date-parts":[[2021,7,15]],"date-time":"2021-07-15T18:15:27Z","timestamp":1626372927000},"page":"2748-2763","update-policy":"https:\/\/doi.org\/10.1158\/crossmark_policy","source":"Crossref","is-referenced-by-count":593,"title":["A Phase I Trial of Regional Mesothelin-Targeted CAR T-cell Therapy in Patients with Malignant Pleural Disease, in Combination with the Anti\u2013PD-1 Agent Pembrolizumab"],"prefix":"10.1158","volume":"11","author":[{"given":"Prasad S.","family":"Adusumilli","sequence":"first","affiliation":[{"name":"1Thoracic Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York."},{"name":"2Cellular Therapeutics Center, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York."},{"name":"3Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, New York."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6109-5790","authenticated-orcid":false,"given":"Marjorie G.","family":"Zauderer","sequence":"additional","affiliation":[{"name":"2Cellular Therapeutics Center, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York."},{"name":"4Thoracic Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Rivi\u00e8re","sequence":"additional","affiliation":[{"name":"3Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, New York."},{"name":"5Michael G. 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