ALVR109, an off-the-shelf partially HLA matched SARS-CoV-2-specific T cell therapy, to treat refractory severe COVID-19 pneumonia in a heart transplant patient : Case report
© 2021 The Authors. American Journal of Transplantation published by Wiley Periodicals LLC on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons..
An unvaccinated adult male heart transplant recipient patient with recalcitrant COVID-19 due to SARS-CoV-2 delta variant with rising nasopharyngeal quantitative viral load was successfully treated with ALVR109, an off-the-shelf SARS-CoV-2-specific T cell therapy. Background immunosuppression included 0.1 mg/kg prednisone, tacrolimus, and mycophenolate mofetil 1 gm twice daily for historical antibody-mediated rejection. Prior therapies included remdesivir, corticosteroids, and tocilizumab, with requirement for high-flow nasal oxygen. Lack of clinical improvement and acutely rising nasopharyngeal viral RNA more than 3 weeks into illness prompted the request of ALVR109 through an emergency IND. The day following the first ALVR109 infusion, the patient's nasopharyngeal SARS-CoV-2 RNA declined from 7.43 to 5.02 log10 RNA copies/ml. On post-infusion day 4, the patient transitioned to low-flow oxygen. Two subsequent infusions of ALVR109 were administered 10 and 26 days after the first; nasopharyngeal SARS-CoV-2 RNA became undetectable on Day 11, and he was discharged the following day on low-flow oxygen 5 weeks after the initial diagnosis of COVID-19. The clinical and virologic improvements observed in this patient following administration of ALVR109 suggest a potential benefit that warrants further exploration in clinical trials.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons - 22(2022), 4 vom: 03. Apr., Seite 1261-1265 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Martits-Chalangari, Katalin [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 05.04.2022 Date Revised 24.01.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/ajt.16927 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM334471109 |
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| 100 | 1 | |a Martits-Chalangari, Katalin |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a ALVR109, an off-the-shelf partially HLA matched SARS-CoV-2-specific T cell therapy, to treat refractory severe COVID-19 pneumonia in a heart transplant patient |b Case report |
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| 520 | |a © 2021 The Authors. American Journal of Transplantation published by Wiley Periodicals LLC on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons. | ||
| 520 | |a An unvaccinated adult male heart transplant recipient patient with recalcitrant COVID-19 due to SARS-CoV-2 delta variant with rising nasopharyngeal quantitative viral load was successfully treated with ALVR109, an off-the-shelf SARS-CoV-2-specific T cell therapy. Background immunosuppression included 0.1 mg/kg prednisone, tacrolimus, and mycophenolate mofetil 1 gm twice daily for historical antibody-mediated rejection. Prior therapies included remdesivir, corticosteroids, and tocilizumab, with requirement for high-flow nasal oxygen. Lack of clinical improvement and acutely rising nasopharyngeal viral RNA more than 3 weeks into illness prompted the request of ALVR109 through an emergency IND. The day following the first ALVR109 infusion, the patient's nasopharyngeal SARS-CoV-2 RNA declined from 7.43 to 5.02 log10 RNA copies/ml. On post-infusion day 4, the patient transitioned to low-flow oxygen. Two subsequent infusions of ALVR109 were administered 10 and 26 days after the first; nasopharyngeal SARS-CoV-2 RNA became undetectable on Day 11, and he was discharged the following day on low-flow oxygen 5 weeks after the initial diagnosis of COVID-19. The clinical and virologic improvements observed in this patient following administration of ALVR109 suggest a potential benefit that warrants further exploration in clinical trials | ||
| 650 | 4 | |a Case Reports | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a antibiotic: antiviral | |
| 650 | 4 | |a clinical research/practice | |
| 650 | 4 | |a heart transplantation/cardiology | |
| 650 | 4 | |a immunobiology | |
| 650 | 4 | |a infection and infectious agents-viral: SARS-CoV-2/COVID-19 | |
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| 700 | 1 | |a Spak, Cedric W |e verfasserin |4 aut | |
| 700 | 1 | |a Askar, Medhat |e verfasserin |4 aut | |
| 700 | 1 | |a Killian, Aaron |e verfasserin |4 aut | |
| 700 | 1 | |a Fisher, Tammy L |e verfasserin |4 aut | |
| 700 | 1 | |a Atillasoy, Ercem |e verfasserin |4 aut | |
| 700 | 1 | |a Marshall, William L |e verfasserin |4 aut | |
| 700 | 1 | |a McNeel, David |e verfasserin |4 aut | |
| 700 | 1 | |a Miller, Michael D |e verfasserin |4 aut | |
| 700 | 1 | |a Mathai, Susan K |e verfasserin |4 aut | |
| 700 | 1 | |a Gottlieb, Robert L |e verfasserin |4 aut | |
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