医学
CD30
淋巴瘤
胃肠病学
间变性大细胞淋巴瘤
环磷酰胺
内科学
外科
毒性
化疗
作者
Jennifer N. Brudno,Danielle Natrakul,Jeremiah Karrs,Nisha Patel,Roberto Maass‐Moreno,Mark A. Ahlman,Lekha Mikkilineni,Jennifer Mann,David F. Stroncek,Steven L. Highfill,Genevieve C. Fromm,Rashmika Patel,Stefania Pittaluga,James N. Kochenderfer
出处
期刊:Blood Advances
[American Society of Hematology]
日期:2023-11-08
标识
DOI:10.1182/bloodadvances.2023011470
摘要
New treatments are needed for relapsed and refractory CD30-expressing lymphomas. We developed a novel anti-CD30 CAR, designated 5F11-28Z. Safety and feasibility of 5F11-28Z-transduced T cells (5F11-T) were evaluated in a phase I dose escalation clinical trial. Patients with CD30-expressing lymphomas received 300 mg/m2 or 500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine on days -5 to -3 followed by infusion of 5F11-T on day 0. Twenty-one patients received 5F11-T infusions. Twenty patients had Classical Hodgkin lymphoma, and 1 had anaplastic large cell lymphoma. Patients were heavily pretreated, with a median of 7 prior lines of therapy and substantial tumor burden, with a median metabolic tumor volume (MTV) of 66.1 mL (range 6.4 - 486.7 mL). The overall response rate was 43%; one patient achieved a complete remission. Median event-free survival was 13 weeks. Eleven patients had cytokine release syndrome (CRS; 52%). One patient had grade 3 CRS, and there was no grade 4-5 CRS. Neurologic toxicity was minimal. Nine patients (43%) had new onset rashes. Two patients (9.5%) received extended courses of corticosteroids for prolonged severe rashes. Five patients (24%) had grade 3-4 cytopenias with recovery time of 30 days or more, and 2 of these patients (9.5%) had prolonged cytopenias with courses complicated by life-threatening sepsis. The trial was halted early due to toxicity. Median peak blood CAR+ cells/µL was 26 (range 1-513), but no infiltration of CAR+ cells was detected in lymph node biopsies. 5F11-T had low efficacy and substantial toxicities, which limit further development of 5F11-T. CT# NCT03049449
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