Safety Infusion of NatuRal KillEr celLs or MEmory T Cells as Adoptive Therapy in COVID-19 pnEumonia or Lymphopenia

Summary

This is a phase I/II clinical trial using adoptive cell therapy with NK cells or memory T cells in patients affected by COVID-19. Severe cases with COVID-19 present a dysregulated immune system with T cell lymphopenia, specially NK cells and memory T cells, and a hyper-inflammatory state. This clinical trial proposes the use of cell therapy for the treatment of patients with worse prognosis due to SARS-CoV-2 infection (those with pneumonia and/or lymphopenia). This is an innovative and a non-pharmacological intervention.

Timeline

Start

2020-09-04

Primary completion

2022-01-13

Completion

2022-03-30

Publications

• Martin-Antonio B, Blanco B, Gonzalez-Murillo A, Hidalgo L, Minguillon J, Perez-Chacon G; Next Generation CART MAD Consortium. Newer generations of multi-target CAR and STAb-T immunotherapeutics: NEXT CART Consortium as a cooperative effort to overcome current limitations. Front Immunol. 2024 May 8;15:1386856. doi: 10.3389/fimmu.2024.1386856. eCollection 2024.
• Ferreras C, Hernandez-Blanco C, Martin-Quiros A, Al-Akioui-Sanz K, Mora-Rillo M, Ibanez F, Diaz-Almiron M, Cano-Ochando J, Lozano-Ojalvo D, Jimenez-Gonzalez M, Goterris R, Sanchez-Zapardiel E, de Paz R, Guerra-Garcia P, Queiruga-Parada J, Molina P, Briones ML, Ruz-Caracuel B, Borobia AM, Carcas AJ, Planelles D, Vicario JL, Moreno MA, Balas A, Llano M, Llorente A, Del Balzo A, Canada C, Garcia MA, Calvin ME, Arenas I, Perez de Diego R, Eguizabal C, Soria B, Solano C, Perez-Martinez A. Results of phase 2 randomized multi-center study to evaluate the safety and efficacy of infusion of memory T cells as adoptive therapy in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia and/or lymphopenia (RELEASE NCT04578210). Cytotherapy. 2024 Jan;26(1):25-35. doi: 10.1016/j.jcyt.2023.10.002. Epub 2023 Oct 29.
• Herrera L, Martin-Inaraja M, Santos S, Ingles-Ferrandiz M, Azkarate A, Perez-Vaquero MA, Vesga MA, Vicario JL, Soria B, Solano C, De Paz R, Marcos A, Ferreras C, Perez-Martinez A, Eguizabal C. Identifying SARS-CoV-2 'memory' NK cells from COVID-19 convalescent donors for adoptive cell therapy. Immunology. 2022 Feb;165(2):234-249. doi: 10.1111/imm.13432. Epub 2021 Dec 2.
• Garcia-Garcia I, Guerra-Garcia P, Ferreras C, Borobia AM, Carcas AJ, Queiruga-Parada J, Vicario JL, Mirones I, Solano C, Eguizabal C, Soria B, Perez-Martinez A. A phase I/II dose-escalation multi-center study to evaluate the safety of infusion of natural killer cells or memory T cells as adoptive therapy in coronavirus pneumonia and/or lymphopenia: RELEASE study protocol. Trials. 2021 Oct 2;22(1):674. doi: 10.1186/s13063-021-05625-7.
• Perez-Martinez A, Mora-Rillo M, Ferreras C, Guerra-Garcia P, Pascual-Miguel B, Mestre-Duran C, Borobia AM, Carcas AJ, Queiruga-Parada J, Garcia I, Sanchez-Zapardiel E, Gasior M, De Paz R, Marcos A, Vicario JL, Balas A, Moreno MA, Eguizabal C, Solano C, Arribas JR, Buckley RM, Montejano R, Soria B. Phase I dose-escalation single centre clinical trial to evaluate the safety of infusion of memory T cells as adoptive therapy in COVID-19 (RELEASE). EClinicalMedicine. 2021 Sep;39:101086. doi: 10.1016/j.eclinm.2021.101086. Epub 2021 Aug 13.
• Del Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available.

Drugs

Indications