CoV-2-STs(George Papanicolaou Hospital)(CoV-2-STs(George Papanicolaou Hospital))

概要

基本信息

药物类型

T细胞疗法

别名

Coronavirus-2-specific T cells(George Papanicolaou Hospital)、SARS-CoV-2-specific T Lymphocytes(George Papanicolaou Hospital)

靶点-

作用方式-

作用机制

免疫细胞毒性

治疗领域

感染呼吸系统疾病

在研适应症-

非在研适应症

新型冠状病毒感染

原研机构

George Papanicolaou Hospital

在研机构-

非在研机构

George Papanicolaou Hospital

权益机构-

最高研发阶段无进展临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

1

项与 CoV-2-STs(George Papanicolaou Hospital) 相关的临床试验

NCT05447013

/ Unknown status临床1/2期IIT

Generation of SARS-CoV-2-specific T Lymphocytes From Recovered Donors and Administration to High-risk COVID-19 Patients

Open-label phase I (single-center)/ phase II (multicenter) with randomization 2:1

开始日期2021-06-02

申办/合作机构

George Papanicolaou Hospital

[+1]

100 项与 CoV-2-STs(George Papanicolaou Hospital) 相关的临床结果

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100 项与 CoV-2-STs(George Papanicolaou Hospital) 相关的转化医学

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100 项与 CoV-2-STs(George Papanicolaou Hospital) 相关的专利（医药）

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3

项与 CoV-2-STs(George Papanicolaou Hospital) 相关的文献（医药）

2024-02-01·International Journal of Infectious Diseases

Long-term efficacy of the peptide-based COVID-19 T cell activator CoVac-1 in healthy adults

Article

作者: Tegeler, Christian M ; Jaeger, Simon U ; Oezbek, Melek Tutku ; Schroeder, Sarah M ; Heitmann, Jonas S ; Denk, Monika ; Fischer, Imma ; Bitzer, Michael ; Michel, Tanja M ; Marconato, Maddalena ; Schindler, Michael ; Salih, Helmut R ; Richter, Marion ; Meisner, Christoph ; Ruetalo, Natalia ; Rammensee, Hans-Georg ; Walz, Juliane S ; Schneiderhan-Marra, Nicole ; Maringer, Yacine ; Wiesmüller, Karl-Heinz ; Tandler, Claudia

OBJECTIVEST cell immunity is key for the control of viral infections including SARS-CoV-2, in particular with regard to immune memory and protection against arising genetic variants.METHODSWe recently evaluated a peptide-based SARS-CoV-2 T cell activator termed CoVac-1 in a first-in-human trial in healthy adults. Here, we report on long-term safety and efficacy data of CoVac-1 until month 12.RESULTSCoVac-1 is well tolerated without long-term immune-related side effects and induces long-lasting anti-viral T cell responses in 100% of study participants, with potent expandability of clusters of differentiation (CD4⁺) and CD8⁺ T cells targeting multiple different CoVac-1 T cell epitopes. T cell responses were associated with stronger injection site reaction. Beyond induction of T cell immunity, 89% of subjects developed CoVac-1-specific immunoglobulin G antibodies which associated with the intensity of the T cell response, indicating that CoVac-1-specific CD4⁺ T cells support the induction of B-cell responses. Vaccination with approved COVID-19 vaccines boosted CoVac-1-specific T cell responses. Overall, a low SARS-CoV-2 infection rate (8.3%) was observed.CONCLUSIONTogether, a single application of CoVac-1 elicits long-lived and broad SARS-CoV-2-specific T cell immunity, which further supports the current evaluation of our T cell activator in patients with congenital or acquired B-cell defects.

2023-08-01·Nature medicine1区 · 医学

SARS-CoV-2-specific T cell therapy for severe COVID-19: a randomized phase 1/2 trial.

1区 · 医学

Article

作者: Anagnostopoulos, Achilles ; Stergiouda, Zoi ; Bitzani, Militsa ; Vogiatzoglou, Anastasios ; Morfesis, Petros ; Theodorakopoulou, Maria ; Chatzika, Georgia ; Fylaktou, Asimina ; Stefanou, Garyfallia ; Bousiou, Zoi ; Karaglani, Antonia ; Papadimitriou, Vasiliki ; Giannaki, Maria ; Giannaki, Chrysavgi ; Siotou, Eleni ; Vallianou, Ioanna ; Stavridou, Fani ; Xochelli, Aliki ; Papalexandri, Apostolia ; Pitsiou, Georgia ; Sileli, Maria ; Karampatakis, Theodoros ; Varsamoudi, Evangelia ; Karavalakis, George ; Serasli, Eva ; Papadopoulou, Anastasia ; Papadopoulou, Efthymia ; Yannaki, Evangelia ; Doumas, Michalis ; Kammenou, Maria ; Georgakopoulou, Aphrodite ; Georgolopoulos, Grigorios ; Kapravelos, Nikolaos ; Kourlaba, Georgia ; Sakellari, Ioanna ; Gounelas, George ; Boukla, Anna ; Papayanni, Penelope-Georgia ; Triantafyllidou, Maria ; Zotou, Eleni ; Koutra, Maria-Georgia ; Apostolou, Dimitra ; Tryfon, Stavros

Despite advances, few therapeutics have shown efficacy in severe coronavirus disease 2019 (COVID-19). In a different context, virus-specific T cells have proven safe and effective. We conducted a randomized (2:1), open-label, phase 1/2 trial to evaluate the safety and efficacy of off-the-shelf, partially human leukocyte antigen (HLA)-matched, convalescent donor-derived severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific T cells (CoV-2-STs) in combination with standard of care (SoC) in patients with severe COVID-19 compared to SoC during Delta variant predominance. After a dose-escalated phase 1 safety study, 90 participants were randomized to receive CoV-2-ST+SoC (n = 60) or SoC only (n = 30). The co-primary objectives of the study were the composite of time to recovery and 30-d recovery rate and the in vivo expansion of CoV-2-STs in patients receiving CoV-2-ST+SoC over SoC. The key secondary objective was survival on day 60. CoV-2-ST+SoC treatment was safe and well tolerated. The study met the primary composite endpoint (CoV-2-ST+SoC versus SoC: recovery rate 65% versus 38%, P = 0.017; median recovery time 11 d versus not reached, P = 0.052, respectively; rate ratio for recovery 1.71 (95% confidence interval 1.03-2.83, P = 0.036)) and the co-primary objective of significant CoV-2-ST expansion compared to SοC (CoV-2-ST+SoC versus SoC, P = 0.047). Overall, in hospitalized patients with severe COVID-19, adoptive immunotherapy with CoV-2-STs was feasible and safe. Larger trials are needed to strengthen the preliminary evidence of clinical benefit in severe COVID-19. EudraCT identifier: 2021-001022-22 .

Frontiers in Immunology2区 · 医学

Two Different Antibody-Dependent Enhancement (ADE) Risks for SARS-CoV-2 Antibodies

2区 · 医学

ArticleOA

作者: Ricke, Darrell O

COVID-19 (SARS-CoV-2) disease severity and stages varies from asymptomatic, mild flu-like symptoms, moderate, severe, critical, and chronic disease. COVID-19 disease progression include lymphopenia, elevated proinflammatory cytokines and chemokines, accumulation of macrophages and neutrophils in lungs, immune dysregulation, cytokine storms, acute respiratory distress syndrome (ARDS), etc. Development of vaccines to severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome coronavirus (MERS-CoV), and other coronavirus has been difficult to create due to vaccine induced enhanced disease responses in animal models. Multiple betacoronaviruses including SARS-CoV-2 and SARS-CoV-1 expand cellular tropism by infecting some phagocytic cells (immature macrophages and dendritic cells) via antibody bound Fc receptor uptake of virus. Antibody-dependent enhancement (ADE) may be involved in the clinical observation of increased severity of symptoms associated with early high levels of SARS-CoV-2 antibodies in patients. Infants with multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 may also have ADE caused by maternally acquired SARS-CoV-2 antibodies bound to mast cells. ADE risks associated with SARS-CoV-2 has implications for COVID-19 and MIS-C treatments, B-cell vaccines, SARS-CoV-2 antibody therapy, and convalescent plasma therapy for patients. SARS-CoV-2 antibodies bound to mast cells may be involved in MIS-C and multisystem inflammatory syndrome in adults (MIS-A) following initial COVID-19 infection. SARS-CoV-2 antibodies bound to Fc receptors on macrophages and mast cells may represent two different mechanisms for ADE in patients. These two different ADE risks have possible implications for SARS-CoV-2 B-cell vaccines for subsets of populations based on age, cross-reactive antibodies, variabilities in antibody levels over time, and pregnancy. These models place increased emphasis on the importance of developing safe SARS-CoV-2 T cell vaccines that are not dependent upon antibodies.

100 项与 CoV-2-STs(George Papanicolaou Hospital) 相关的药物交易

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