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Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy?

ABSTRACT: CAR-T cells therapy can give rise to most common and concerning two side effects - cytokine release syndrome (CRS) and neurotoxicity. But in our CD19 CAR-T cells therapy clinical trial, we observed 1 out of 17 patients with B-cell acute lymphoblastic leukemia (B-ALL) developed acute myelofibrosis(AMF) after grade IV CRS post to the CD19 CAR-T cells therapy. This finding suggests that the CAR-T cells therapy may have rare and serious AMF, which we should pay important attention to. Trial registration:NCT02968472. Registered 18 November 2016 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02968472.

SUBMITTER: Lai X

PROVIDER: S-EPMC8291836 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy?

Lai Xun X Sun Yun Yan YY Chang Lung Ji LJ Ma Yu Ru YR Gu Xue Zhong XZ Yao Xiang Mei XM Nie Bo B Wen Yan Y Zhang Xue Mei XM Jiang Ya Xian YX Yang Hui H Yu Li Qun LQ Fang Ming Jing MJ Wang Ling L Yuan Bo Xue X

Bioengineered 20201201 1

CAR-T cells therapy can give rise to most common and concerning two side effects - cytokine release syndrome (CRS) and neurotoxicity. But in our CD19 CAR-T cells therapy clinical trial, we observed 1 out of 17 patients with B-cell acute lymphoblastic leukemia (B-ALL) developed acute myelofibrosis(AMF) after grade IV CRS post to the CD19 CAR-T cells therapy. This finding suggests that the CAR-T cells therapy may have rare and serious AMF, which we should pay important attention to. Trial registra ...[more]

PMID: 32772769

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Project description:ObjectiveInitial success with chimeric antigen receptor-modified T cell therapy for relapsed/refractory acute lymphoblastic leukemia is leading to expanded use through multicenter trials. Cytokine release syndrome, the most severe toxicity, presents a novel critical illness syndrome with limited data regarding diagnosis, prognosis, and therapy. We sought to characterize the timing, severity, and intensive care management of cytokine release syndrome after chimeric antigen receptor-modified T cell therapy.DesignRetrospective cohort study.SettingAcademic children's hospital.PatientsThirty-nine subjects with relapsed/refractory acute lymphoblastic leukemia treated with chimeric antigen receptor-modified T cell therapy on a phase I/IIa clinical trial (ClinicalTrials.gov number NCT01626495).InterventionsAll subjects received chimeric antigen receptor-modified T cell therapy. Thirteen subjects with cardiovascular dysfunction were treated with the interleukin-6 receptor antibody tocilizumab.Measurements and main resultsEighteen subjects (46%) developed grade 3-4 cytokine release syndrome, with prolonged fever (median, 6.5 d), hyperferritinemia (median peak ferritin, 60,214 ng/mL), and organ dysfunction. Fourteen (36%) developed cardiovascular dysfunction treated with vasoactive infusions a median of 5 days after T cell therapy. Six (15%) developed acute respiratory failure treated with invasive mechanical ventilation a median of 6 days after T cell therapy; five met criteria for acute respiratory distress syndrome. Encephalopathy, hepatic, and renal dysfunction manifested later than cardiovascular and respiratory dysfunction. Subjects had a median of 15 organ dysfunction days (interquartile range, 8-20). Treatment with tocilizumab in 13 subjects resulted in rapid defervescence (median, 4 hr) and clinical improvement.ConclusionsGrade 3-4 cytokine release syndrome occurred in 46% of patients following T cell therapy for relapsed/refractory acute lymphoblastic leukemia. Clinicians should be aware of expanding use of this breakthrough therapy and implications for critical care units in cancer centers.

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Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy?

Publications

Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy?

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