NCT04578210: RELEASE

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

Completed Phase 1, PHASE2 Last updated 1 June 2023

What this trial tests

Phase 1, PHASE2 trial testing T memory cells and NK cells in Corona Virus Infection in 84 participants. Completed in 30 March 2022.

Timeline

4 September 2020

Primary endpoint
13 January 2022

30 March 2022

Quick facts

Lead sponsor	Instituto de Investigación Hospital Universitario La Paz
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	84
Start date	4 September 2020
Primary completion	13 January 2022
Estimated completion	30 March 2022
Sites	1 location across Spain

Drugs / interventions tested

• T memory cells and NK cells — full drug profile →

Conditions studied

• Corona Virus Infection — all drugs for Corona Virus Infection →

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Who can join

Under 80, any sex, with Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
2. Natural Killer Cells in SARS-CoV-2 Infection: Pathophysiology and Therapeutic Implications.
   Di Vito C, Calcaterra F, Coianiz N, Terzoli S, et al · · 2022 · cited 55× · PMID 35844604 · DOI 10.3389/fimmu.2022.888248
3. SARS-CoV-2-Specific Memory T Lymphocytes From COVID-19 Convalescent Donors: Identification, Biobanking, and Large-Scale Production for Adoptive Cell Therapy.
   Ferreras C, Pascual-Miguel B, Mestre-Durán C, Navarro-Zapata A, et al · · 2021 · cited 41× · PMID 33718360 · DOI 10.3389/fcell.2021.620730
4. The contributory role of lymphocyte subsets, pathophysiology of lymphopenia and its implication as prognostic and therapeutic opportunity in COVID-19.
   Delshad M, Tavakolinia N, Pourbagheri-Sigaroodi A, Safaroghli-Azar A, et al · · 2021 · cited 33× · PMID 33765611 · DOI 10.1016/j.intimp.2021.107586
5. Innate and Adaptive Immunity during SARS-CoV-2 Infection: Biomolecular Cellular Markers and Mechanisms.
   Brown B, Ojha V, Fricke I, Al-Sheboul SA, et al · · 2023 · cited 32× · PMID 36851285 · DOI 10.3390/vaccines11020408
6. Arming Immune Cells for Battle: A Brief Journey through the Advancements of T and NK Cell Immunotherapy.
   Wendel P, Reindl LM, Bexte T, Künnemeyer L, et al · · 2021 · cited 32× · PMID 33807011 · DOI 10.3390/cancers13061481
7. Identifying SARS-CoV-2 'memory' NK cells from COVID-19 convalescent donors for adoptive cell therapy.
   Herrera L, Martin-Inaraja M, Santos S, Inglés-Ferrándiz M, et al · · 2022 · cited 31× · PMID 34775592 · DOI 10.1111/imm.13432
8. The role of NK cells in fighting the virus infection and sepsis.
   Ma L, Li Q, Cai S, Peng H, et al · · 2021 · cited 31× · PMID 34400893 · DOI 10.7150/ijms.59898