Núria Martínez-Cibrián, Valentín Ortiz-Maldonado, Marta Español-Rego, Leticia Alserawan, Sergio Navarro, Nil Albiol, Miquel Lozano, Paola Charry, Laura Magnano, Andrea Rivero, Juan G. Correa, Pablo Mozas, Albert Cortés-Bullich, Carlos Jiménez-Vicente, Eva Giné, Mercedes Montoro-Lorite, Carla Ramos, Pilar Ayora, Hugo Calderón, María Sánchez-Castañón, Daniel Benítez-Ribas, Juan J. Mata-Molanes, Kelly Rojas, Xavier Setoaín, Sonia Rodríguez, Adrià Murias, Pau Alcubilla, Sara Varea, Eulalia Olesti, Mireia Bachiller, María Calvo-Orteu, Carla Sans-Pola, Joaquín Sáez-Peñataro, Carlos Fernández de Larrea, Armando López-Guillermo, E. Azucena González-Navarro, Manel Juan, Julio Delgado
{"title":"抗cd19嵌合抗原受体t细胞产物varnimcabtagene自体醇治疗复发/难治性滤泡性淋巴瘤的疗效和安全性","authors":"Núria Martínez-Cibrián, Valentín Ortiz-Maldonado, Marta Español-Rego, Leticia Alserawan, Sergio Navarro, Nil Albiol, Miquel Lozano, Paola Charry, Laura Magnano, Andrea Rivero, Juan G. Correa, Pablo Mozas, Albert Cortés-Bullich, Carlos Jiménez-Vicente, Eva Giné, Mercedes Montoro-Lorite, Carla Ramos, Pilar Ayora, Hugo Calderón, María Sánchez-Castañón, Daniel Benítez-Ribas, Juan J. Mata-Molanes, Kelly Rojas, Xavier Setoaín, Sonia Rodríguez, Adrià Murias, Pau Alcubilla, Sara Varea, Eulalia Olesti, Mireia Bachiller, María Calvo-Orteu, Carla Sans-Pola, Joaquín Sáez-Peñataro, Carlos Fernández de Larrea, Armando López-Guillermo, E. Azucena González-Navarro, Manel Juan, Julio Delgado","doi":"10.1002/hem3.70166","DOIUrl":null,"url":null,"abstract":"<p>We report the outcome of patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated with varnimcabtagene autoleucel (var-cel), an academic anti-CD19 chimeric antigen receptor (CAR) T-cell product. Patients were included in the CART19-BE-01 clinical trial and a compassionate use program. Twenty-seven patients with FL were treated. Cytokine release syndrome (any grade) occurred in 55% of patients (4% Grade ≥3). Only 1 case (4%) of Grade 1 neurotoxicity was documented. The objective response rate was 100% at Day +100 (93% complete response rate), and the 3-year duration of response was 78%. The 3-year progression-free survival and overall survival were 78% and 81%, respectively. All patients developed B-cell aplasia, and the 3-year incidence of B-cell recovery was 17%. In conclusion, patients with R/R FL treated with var-cel obtained excellent disease control, with prolonged CAR T-cell survival and manageable toxicity. This trial was registered as NCT03144583.</p>","PeriodicalId":12982,"journal":{"name":"HemaSphere","volume":"9 9","pages":""},"PeriodicalIF":14.6000,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/hem3.70166","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of the academic anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma\",\"authors\":\"Núria Martínez-Cibrián, Valentín Ortiz-Maldonado, Marta Español-Rego, Leticia Alserawan, Sergio Navarro, Nil Albiol, Miquel Lozano, Paola Charry, Laura Magnano, Andrea Rivero, Juan G. Correa, Pablo Mozas, Albert Cortés-Bullich, Carlos Jiménez-Vicente, Eva Giné, Mercedes Montoro-Lorite, Carla Ramos, Pilar Ayora, Hugo Calderón, María Sánchez-Castañón, Daniel Benítez-Ribas, Juan J. Mata-Molanes, Kelly Rojas, Xavier Setoaín, Sonia Rodríguez, Adrià Murias, Pau Alcubilla, Sara Varea, Eulalia Olesti, Mireia Bachiller, María Calvo-Orteu, Carla Sans-Pola, Joaquín Sáez-Peñataro, Carlos Fernández de Larrea, Armando López-Guillermo, E. Azucena González-Navarro, Manel Juan, Julio Delgado\",\"doi\":\"10.1002/hem3.70166\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>We report the outcome of patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated with varnimcabtagene autoleucel (var-cel), an academic anti-CD19 chimeric antigen receptor (CAR) T-cell product. Patients were included in the CART19-BE-01 clinical trial and a compassionate use program. Twenty-seven patients with FL were treated. Cytokine release syndrome (any grade) occurred in 55% of patients (4% Grade ≥3). Only 1 case (4%) of Grade 1 neurotoxicity was documented. The objective response rate was 100% at Day +100 (93% complete response rate), and the 3-year duration of response was 78%. The 3-year progression-free survival and overall survival were 78% and 81%, respectively. All patients developed B-cell aplasia, and the 3-year incidence of B-cell recovery was 17%. In conclusion, patients with R/R FL treated with var-cel obtained excellent disease control, with prolonged CAR T-cell survival and manageable toxicity. 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Efficacy and safety of the academic anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma
We report the outcome of patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated with varnimcabtagene autoleucel (var-cel), an academic anti-CD19 chimeric antigen receptor (CAR) T-cell product. Patients were included in the CART19-BE-01 clinical trial and a compassionate use program. Twenty-seven patients with FL were treated. Cytokine release syndrome (any grade) occurred in 55% of patients (4% Grade ≥3). Only 1 case (4%) of Grade 1 neurotoxicity was documented. The objective response rate was 100% at Day +100 (93% complete response rate), and the 3-year duration of response was 78%. The 3-year progression-free survival and overall survival were 78% and 81%, respectively. All patients developed B-cell aplasia, and the 3-year incidence of B-cell recovery was 17%. In conclusion, patients with R/R FL treated with var-cel obtained excellent disease control, with prolonged CAR T-cell survival and manageable toxicity. This trial was registered as NCT03144583.
期刊介绍：
HemaSphere, as a publication, is dedicated to disseminating the outcomes of profoundly pertinent basic, translational, and clinical research endeavors within the field of hematology. The journal actively seeks robust studies that unveil novel discoveries with significant ramifications for hematology.
In addition to original research, HemaSphere features review articles and guideline articles that furnish lucid synopses and discussions of emerging developments, along with recommendations for patient care.
Positioned as the foremost resource in hematology, HemaSphere augments its offerings with specialized sections like HemaTopics and HemaPolicy. These segments engender insightful dialogues covering a spectrum of hematology-related topics, including digestible summaries of pivotal articles, updates on new therapies, deliberations on European policy matters, and other noteworthy news items within the field. Steering the course of HemaSphere are Editor in Chief Jan Cools and Deputy Editor in Chief Claire Harrison, alongside the guidance of an esteemed Editorial Board comprising international luminaries in both research and clinical realms, each representing diverse areas of hematologic expertise.
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