Autologous EBV-specific T cell treatment results in sustained responses in patients with advanced extranodal NK/T lymphoma: results of a multicenter study
- 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.
- 강혜진; 김석진; 김원석; 김진석; 서철원; 윤덕현; 윤상은; 이용표; 조재철; Arnaud Jaccard; Catherine M Bollard; Cliona M Rooney; Daniel Y Lee; Emmanuel Bachy; Eric D Jacobsen; Felipe Suarez; Helen E Heslop; Hun Ju Lee; Jia Ruan; John Radford; Jonathan E Brammer; Katherin E Combs; Kirit M Ardeshna; Kurt C Gunter; Lihua E Budde
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- Epstein-Barr virus; Extranodal NK/T-cell lymphoma; Immunotherapy; Relapsed and refractory.
- ANNALS OF HEMATOLOGY
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