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A pilot study of multi-antigen stimulated cell therapy-I plus camrelizumab and apatinib in patients with advanced bone and soft-tissue sarcomas

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机构: [1]Department of Oncology, Shanghai Sixth People’s Hospital Afliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China [2]Department of Radiology, Shanghai Sixth People’s Hospital Afliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China [3]Department of Orthopedic Oncology, the Afliated Hospital of Jiangxi University of Traditional Chinese Medicine, Jiangxi, China [4]Department of Orthopedic Oncology, Changzheng Hospital of Naval Military Medical University, Shanghai, China [5]Department of Oncology, Shanghai Eighth People’s Hospital, Shanghai, China [6]Department of Oncology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China [7]HRYZ Biotech Co, Shenzhen, China [8]Department of Orthopedic, Shanghai Sixth People’s Hospital Afliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China [9]Shanghai Clinical Research Ward (SCRW), Shanghai Sixth People’s Hospital Afliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China.
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关键词: Cell-based immunotherapy MASCT-I Camrelizumab Apatinib Sarcoma

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Cell-based  immunotherapy shows the therapeutic potential in sarcomas, in addition to angiogenesis-targeted tyrosine kinase inhibitor (TKI) and immune checkpoint inhibitor (ICI). Multi-antigen stimulated cell therapy-I (MASCT-I) technology is a sequential immune cell therapy for cancer, which composes of multiple antigen-loaded dendritic cell (DC) vaccines followed by the adoptive transfer of anti-tumor effector T-cells.In this phase 1 study, we assessed MASCT-I plus camrelizumab (an ICI against PD-1) and apatinib (a highly selective TKI targeting VEGFR2) in patients with unresectable recurrent or metastatic bone and soft-tissue sarcoma after at least one line of prior systemic therapy. One MASCT-I course consisted of 3 DC subcutaneous injections, followed by 3 active T cell infusions administered 18-27 days after each DC injection. In schedule-I group, 3 DC injections were administered with a 28-day interval in all courses; in schedule-II group, 3 DC injections were administered with a 7-day interval in the first course and with a 28-day interval thereafter. All patients received intravenous camrelizumab 200 mg every 3 weeks and oral apatinib 250 mg daily.From October 30, 2019, to August 12, 2021, 19 patients were enrolled and randomly assigned to schedule-I group (n = 9) and schedule-II group (n = 10). Of the 19 patients, 11 (57.9%) experienced grade 3 or 4 treatment-related adverse events. No treatment-related deaths occurred. Patients in schedule-II group showed similar objective response rate (ORR) with those in schedule-I group (30.0% versus 33.3%) but had higher disease control rate (DCR; 90.0% versus 44.4%) and longer median progression-free survival (PFS; 7.7 versus 4.0 months). For the 13 patients with soft-tissue sarcomas, the ORR was 30.8%, DCR was 76.9%, and median PFS was 12.9 months; for the 6 patients with osteosarcomas, the ORR was 33.3%, the DCR was 50.0%, and median PFS was 5.7 months.Overall, MASCT-I plus camrelizumab and apatinib was safe and showed encouraging efficacy in advanced bone and soft-tissue sarcoma, and schedule-II administration method was recommended.ClinicalTrials.gov, NCT04074564.© 2023. The Author(s).

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大类 | 1 区 医学
小类 | 1 区 医学:内科
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大类 | 1 区 医学
小类 | 1 区 医学:内科
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Q1 MEDICINE, GENERAL & INTERNAL
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Q1 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]Department of Oncology, Shanghai Sixth People’s Hospital Afliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China
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通讯机构: [1]Department of Oncology, Shanghai Sixth People’s Hospital Afliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China [9]Shanghai Clinical Research Ward (SCRW), Shanghai Sixth People’s Hospital Afliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China.
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