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Leukemia & lymphoma · 2023

Point-of-care anti-CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory follicular lymphoma.

Клиническое исследование II фазыКлиническое исследование I фазыСтатьяПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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Fried Shalev, Shkury Eden, Itzhaki Orit, Sdayoor Inbal, Yerushalmi Ronit, Shem-Tov Noga, Danylesko Ivetta, Jacoby Elad, Shouval Roni, Kedmi Meirav, Marcus Ronit, Nagler Arnon, Shimoni Avichai, Avigdor Abraham

Аннотация

Patients with relapsed/refractory follicular lymphoma (R/R-FL) often require multiple treatment lines. We performed a phase 1b/2 single-center clinical trial of autologous point-of-care anti-CD19 chimeric antigen receptor (CAR) T-cells in R/R-FL patients treated patients with ≥ 2 treatment lines. All 26 patients enrolled received CAR T-cell infusion at a median of 11 days after leukapheresis. Seventy-seven percent of patients had POD24. At enrollment, disease stage was III-IV in 85% of the patients, 77% had high-risk FLIPI score, and 77% had progressive disease. Grade III-IV cytokine release and immune effector cell-associated neurotoxicity syndromes occurred in 12% and 16% of the patients, respectively. Overall response rate at 1-month was 88%. The median follow-up was 15.4 months. One-year overall and progression-free survival were 100% and 63%, respectively. In conclusion, point-of-care CAR T-cell, manufactured within 11 days, induced a high response rate with an acceptable safety profile in patients with high-risk R/R-FL.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты