The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19
Summary: The severity of COVID 19 symptoms has a direct correlation with lymphopenia, affecting natural killer (NK) cells. SARS-CoV-2 specific “memory” NK cells obtained from convalescent donors can be used as cell immunotherapy. In 2022 a phase I, dose-escalation, single center clinical trial was c...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-02-01
|
| Series: | iScience |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589004224029250 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1841544005503942656 |
|---|---|
| author | Clara Hernández-Blanco Karima Al-Akioui-Sanz Lara Herrera Cristina Aguirre-Portolés Daniel Lozano-Ojalvo Leticia Pérez-Rodriguez Jordi Cano-Ochando Pilar Guerra-García Alejandro Martín-Quirós José Luis Vicario Silvia Santos Miguel Ángel Pérez-Vaquero Miguel Ángel Vesga Alberto M. Borobia Antonio J. Carcas Antonio Balas Miguel Ángel Moreno Rebeca Pérez de Diego Mercedes Gasior Bernat Soria Cristina Eguizabal Antonio Pérez-Martínez |
| author_facet | Clara Hernández-Blanco Karima Al-Akioui-Sanz Lara Herrera Cristina Aguirre-Portolés Daniel Lozano-Ojalvo Leticia Pérez-Rodriguez Jordi Cano-Ochando Pilar Guerra-García Alejandro Martín-Quirós José Luis Vicario Silvia Santos Miguel Ángel Pérez-Vaquero Miguel Ángel Vesga Alberto M. Borobia Antonio J. Carcas Antonio Balas Miguel Ángel Moreno Rebeca Pérez de Diego Mercedes Gasior Bernat Soria Cristina Eguizabal Antonio Pérez-Martínez |
| author_sort | Clara Hernández-Blanco |
| collection | DOAJ |
| description | Summary: The severity of COVID 19 symptoms has a direct correlation with lymphopenia, affecting natural killer (NK) cells. SARS-CoV-2 specific “memory” NK cells obtained from convalescent donors can be used as cell immunotherapy. In 2022 a phase I, dose-escalation, single center clinical trial was conducted to evaluate the safety and feasibility of the infusion of CD3−/CD56+ NK cells against moderate/severe cases of COVID-19 (NCT04578210). Six participants with pneumonia and/or lymphopenia were infused. Four patients received a single-dose infusion of NK cells of 1×106/kg, and the following two patients a dose of 2×106/kg of NK cells. All participants’ clinical status and inflammation markers were monitored. No serious adverse events were reported after infusion. Exploratory outcomes included the donor chimerism, NK-cell immunophenotype evolution, and immune lymphocyte reconstitution. This study provides preliminary evidence supporting the idea that treatment of COVID-19 patients with moderate/severe symptoms using NK from COVID-19 convalescent donors is feasible and safe. |
| format | Article |
| id | doaj-art-97ba4ac5d1b34a089f0a13af6f6e6832 |
| institution | Kabale University |
| issn | 2589-0042 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | iScience |
| spelling | doaj-art-97ba4ac5d1b34a089f0a13af6f6e68322025-01-13T04:19:05ZengElsevieriScience2589-00422025-02-01282111698The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19Clara Hernández-Blanco0Karima Al-Akioui-Sanz1Lara Herrera2Cristina Aguirre-Portolés3Daniel Lozano-Ojalvo4Leticia Pérez-Rodriguez5Jordi Cano-Ochando6Pilar Guerra-García7Alejandro Martín-Quirós8José Luis Vicario9Silvia Santos10Miguel Ángel Pérez-Vaquero11Miguel Ángel Vesga12Alberto M. Borobia13Antonio J. Carcas14Antonio Balas15Miguel Ángel Moreno16Rebeca Pérez de Diego17Mercedes Gasior18Bernat Soria19Cristina Eguizabal20Antonio Pérez-Martínez21Internal Medicine Department, University Hospital La Paz, Madrid, Spain; Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, SpainHospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain; Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain; CNIO Pediatric OncoHematology Clinical Research Unit, Madrid, SpainCell Therapy, Stem Cells and Tissues Group, Biobizkaia Health Research Institute, Barakaldo, Spain; Advanced Therapies Unit, Basque Center of Blood Transfusion and Human Tissues, Osakidetza, Galdakao, Spain; Red Española de Terapias Avanzadas (TERAV), Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS RD21/0017/0024, RICORS RD24/0014/0025, RICORS RD21/0017/0025, RICORS RD24/0014/0024), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Red de Inmunoterapia del Cáncer “REINCA” (RED2022-134831-T), Madrid, SpainHospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain; CNIO Pediatric OncoHematology Clinical Research Unit, Madrid, SpainDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Food Science Research Institute (CIAL, CSIC-UAM), Madrid, SpainPrecision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USAPrecision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Microbiology National Centre, Instituto de Salud Carlos III, Madrid, SpainHospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain; Clinical Trials Unit (UCICEC), University Hospital La Paz, Madrid, SpainEmergency Unit, Internal Medicine Department, University Hospital La Paz, Madrid, SpainHistocompatibility, Centro de Transfusión de la Comunidad de Madrid, Madrid, SpainCell Therapy, Stem Cells and Tissues Group, Biobizkaia Health Research Institute, Barakaldo, Spain; Advanced Therapies Unit, Basque Center of Blood Transfusion and Human Tissues, Osakidetza, Galdakao, Spain; Red Española de Terapias Avanzadas (TERAV), Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS RD21/0017/0024, RICORS RD24/0014/0025, RICORS RD21/0017/0025, RICORS RD24/0014/0024), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Red de Inmunoterapia del Cáncer “REINCA” (RED2022-134831-T), Madrid, SpainCell Therapy, Stem Cells and Tissues Group, Biobizkaia Health Research Institute, Barakaldo, Spain; Advanced Therapies Unit, Basque Center of Blood Transfusion and Human Tissues, Osakidetza, Galdakao, Spain; Red Española de Terapias Avanzadas (TERAV), Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS RD21/0017/0024, RICORS RD24/0014/0025, RICORS RD21/0017/0025, RICORS RD24/0014/0024), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Red de Inmunoterapia del Cáncer “REINCA” (RED2022-134831-T), Madrid, SpainCell Therapy, Stem Cells and Tissues Group, Biobizkaia Health Research Institute, Barakaldo, Spain; Advanced Therapies Unit, Basque Center of Blood Transfusion and Human Tissues, Osakidetza, Galdakao, Spain; Red Española de Terapias Avanzadas (TERAV), Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS RD21/0017/0024, RICORS RD24/0014/0025, RICORS RD21/0017/0025, RICORS RD24/0014/0024), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Red de Inmunoterapia del Cáncer “REINCA” (RED2022-134831-T), Madrid, SpainHospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain; Clinical Trials Unit (UCICEC), University Hospital La Paz, Madrid, SpainHospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain; Clinical Trials Unit (UCICEC), University Hospital La Paz, Madrid, Spain; Faculty of Medicine Universidad Autónoma de Madrid, Madrid, SpainHistocompatibility, Centro de Transfusión de la Comunidad de Madrid, Madrid, SpainHistocompatibility, Centro de Transfusión de la Comunidad de Madrid, Madrid, SpainHospital La Paz Institute for Health Research (IdiPAZ), Madrid, SpainHematology Department, Hospital Universitario La Paz, Madrid, SpainAlicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain; Institute of Bioengineering, Miguel Hernández University, Elche, Alicante, SpainCell Therapy, Stem Cells and Tissues Group, Biobizkaia Health Research Institute, Barakaldo, Spain; Advanced Therapies Unit, Basque Center of Blood Transfusion and Human Tissues, Osakidetza, Galdakao, Spain; Red Española de Terapias Avanzadas (TERAV), Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS RD21/0017/0024, RICORS RD24/0014/0025, RICORS RD21/0017/0025, RICORS RD24/0014/0024), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Red de Inmunoterapia del Cáncer “REINCA” (RED2022-134831-T), Madrid, Spain; Corresponding authorHospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain; CNIO Pediatric OncoHematology Clinical Research Unit, Madrid, Spain; Red Española de Terapias Avanzadas (TERAV), Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS RD21/0017/0024, RICORS RD24/0014/0025, RICORS RD21/0017/0025, RICORS RD24/0014/0024), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Pediatric Hemato-Oncology Department, University Hospital La Paz, Madrid, Spain; Histocompatibility, Centro de Transfusión de la Comunidad de Madrid, Madrid, Spain; Faculty of Medicine Universidad Autónoma de Madrid, Madrid, Spain; Corresponding authorSummary: The severity of COVID 19 symptoms has a direct correlation with lymphopenia, affecting natural killer (NK) cells. SARS-CoV-2 specific “memory” NK cells obtained from convalescent donors can be used as cell immunotherapy. In 2022 a phase I, dose-escalation, single center clinical trial was conducted to evaluate the safety and feasibility of the infusion of CD3−/CD56+ NK cells against moderate/severe cases of COVID-19 (NCT04578210). Six participants with pneumonia and/or lymphopenia were infused. Four patients received a single-dose infusion of NK cells of 1×106/kg, and the following two patients a dose of 2×106/kg of NK cells. All participants’ clinical status and inflammation markers were monitored. No serious adverse events were reported after infusion. Exploratory outcomes included the donor chimerism, NK-cell immunophenotype evolution, and immune lymphocyte reconstitution. This study provides preliminary evidence supporting the idea that treatment of COVID-19 patients with moderate/severe symptoms using NK from COVID-19 convalescent donors is feasible and safe.http://www.sciencedirect.com/science/article/pii/S2589004224029250ImmunologyCell biology |
| spellingShingle | Clara Hernández-Blanco Karima Al-Akioui-Sanz Lara Herrera Cristina Aguirre-Portolés Daniel Lozano-Ojalvo Leticia Pérez-Rodriguez Jordi Cano-Ochando Pilar Guerra-García Alejandro Martín-Quirós José Luis Vicario Silvia Santos Miguel Ángel Pérez-Vaquero Miguel Ángel Vesga Alberto M. Borobia Antonio J. Carcas Antonio Balas Miguel Ángel Moreno Rebeca Pérez de Diego Mercedes Gasior Bernat Soria Cristina Eguizabal Antonio Pérez-Martínez The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19 iScience Immunology Cell biology |
| title | The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19 |
| title_full | The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19 |
| title_fullStr | The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19 |
| title_full_unstemmed | The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19 |
| title_short | The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19 |
| title_sort | phase i release clinical trial to evaluate the safety of nk cells in covid 19 |
| topic | Immunology Cell biology |
| url | http://www.sciencedirect.com/science/article/pii/S2589004224029250 |
| work_keys_str_mv | AT clarahernandezblanco thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT karimaalakiouisanz thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT laraherrera thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT cristinaaguirreportoles thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT daniellozanoojalvo thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT leticiaperezrodriguez thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT jordicanoochando thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT pilarguerragarcia thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT alejandromartinquiros thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT joseluisvicario thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT silviasantos thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT miguelangelperezvaquero thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT miguelangelvesga thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT albertomborobia thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT antoniojcarcas thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT antoniobalas thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT miguelangelmoreno thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT rebecaperezdediego thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT mercedesgasior thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT bernatsoria thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT cristinaeguizabal thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT antonioperezmartinez thephaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT clarahernandezblanco phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT karimaalakiouisanz phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT laraherrera phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT cristinaaguirreportoles phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT daniellozanoojalvo phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT leticiaperezrodriguez phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT jordicanoochando phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT pilarguerragarcia phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT alejandromartinquiros phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT joseluisvicario phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT silviasantos phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT miguelangelperezvaquero phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT miguelangelvesga phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT albertomborobia phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT antoniojcarcas phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT antoniobalas phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT miguelangelmoreno phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT rebecaperezdediego phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT mercedesgasior phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT bernatsoria phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT cristinaeguizabal phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 AT antonioperezmartinez phaseireleaseclinicaltrialtoevaluatethesafetyofnkcellsincovid19 |