Autologous EBV-specific T cell treatment results in sustained responses in patients with advanced extranodal NK/T lymphoma: results of a multicenter study

• Published in: Annals of hematology 2021-10, Vol.100 (10), p.2529-2539
• Main Authors: Kim, Won Seog, Oki, Yasuhiro, Kim, Seok Jin, Yoon, Sang Eun, Ardeshna, Kirit M., Lin, Yi, Ruan, Jia, Porcu, Pierluigi, Brammer, Jonathan E., Jacobsen, Eric D., Yoon, Dok Hyun, Suh, Cheolwon, Suarez, Felipe, Radford, John, Budde, Lihua E., Kim, Jin Seok, Bachy, Emmanuel, Lee, Hun Ju, Bollard, Catherine M., Jaccard, Arnaud, Kang, Hye Jin, Inman, Shannon, Murray, Maryann, Combs, Katherin E., Lee, Daniel Y., Advani, Ranjana, Gunter, Kurt C., Rooney, Cliona M., Heslop, Helen E.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Clinical trials; Epstein-Barr Virus Infections - complications; Epstein-Barr Virus Infections - immunology; Epstein-Barr Virus Infections - therapy; Female; Hematology; Herpesvirus 4, Human - immunology; Humans; Immunotherapy; Immunotherapy, Adoptive; Lymphocytes; Lymphoma, Extranodal NK-T-Cell - complications; Lymphoma, Extranodal NK-T-Cell - immunology; Lymphoma, Extranodal NK-T-Cell - therapy; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Article; T-Lymphocytes - immunology; T-Lymphocytes - transplantation; Treatment Outcome; Young Adult
• ISSN: 0939-5555; 1432-0584
• DOI: 10.1007/s00277-021-04558-0

We conducted a phase II clinical trial to develop an autologous EBV-specific T cell product (baltaleucel T) for advanced, relapsed ENKTL. Among 47 patients who provided whole blood starting material for manufacturing the product, 15 patients received a median of 4 doses of baltaleucel T. Thirty-two (68%) patients did not receive baltaleucel-T due to manufacturing failure, rapid disease progression, and death. Of the 15 patients, 10 patients had measurable disease at baseline (salvage cohort), and 5 patients had no disease at baseline assessment (adjuvant cohort). In the 15 patients, the median follow-up duration was 10.2 months (range 2.0–23.5 months), median progression-free survival (PFS) was 3.9 months, and the median overall survival (OS) was not reached. Patients in the salvage cohort achieved a 30% complete response (CR) and a 50% overall response rate (ORR). In the adjuvant cohort, disease progression was reported in three patients and two patients did not relapse during study follow-up. When we compared survival outcomes of seven responders and eight non-responders, the PFS ( P = 0.001) and OS ( P = 0.014) of responders proved statistically superior to that of non-responders. Baltaleucel-T was well tolerated. We have performed a phase II clinical trial of autologous EBV-specific T cell treatment (baltaleucel-T) in R/R ENKTL. Autologous EBV-specific T cells were well tolerated and demonstrated single-agent activity in R/R ENTKL.