Safety Infusion of NatuRal KillEr celLs or MEmory T Cells as Adoptive Therapy in COVID-19 pnEumonia or Lymphopenia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Corona Virus Infection
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This Phase I/II escalating-dose clinical trial is a randomized study to determine safety, tolerability, alloreactivity and efficacy of cell therapy with adoptive cell therapy of NK cells or memory T cells in patients affected by COVID-19 Donors will be patientsrecovered from COVID-19 Will be 2 arms A: allogeneic T memory cells B: allogeneic NK cells There will be two consecutive phases: The first dose escalation focuses on determining safety and the recommended dose for the second segment Phase I: Patients with SARS-CoV-2+ pneumonia and/or lymphopenia and O2Sat ? 94% on room air at screening, with no oxygen required or with an oxygen need of ? 2.5 lpm in nasal cannula, will be selected This phase has a single ascending dose design with up to 3 planned dose levels for each arm The second phase extends the safety study Phase II: Patients with SARS-CoV-2+ pneumonia and/or lymphopenia and O2Sat ? 94% on room air at screening, requiring or not oxygen supplementation Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 80 years
- Gender
- Both males and females
Description
In this phase I/II trial natural killer (NK) cells or memory T lymphocytes will be infused from donors who have recovered from COVID-19 and have complete resolution of symptoms for at least 14 days. There will be two arms based on the biology of the donor and the patient: Infusion of NK cells which ...
In this phase I/II trial natural killer (NK) cells or memory T lymphocytes will be infused from donors who have recovered from COVID-19 and have complete resolution of symptoms for at least 14 days. There will be two arms based on the biology of the donor and the patient: Infusion of NK cells which are cells of the innate immune system that can eliminate virally infected cells. Infusion of memory T cells which have the SARS-COV-2 memory T cell repertoire. The investigators expect a quick recovery of the patients with pneumonia or lymphopenia for two reasons: NK cells act quickly after a viral infection. The number and function of NK cells correlates with the severity of another coronavirus infection, Severe Acute Respiratory Syndrome (SARS), originated in China in 2002. Moreover, the investigators have previous successful experience with other viruses such as CMV, EBV and HHV-6. The pool of memory T cells will increase in patients. Memory T cell levels are low in these patients. These lymphocytes have long-life memory, which upon reencountering SARS-CoV-2 will induce enhanced effector function resulting in greater protection of the patient. Patients who have recovered from COVID-19 are the ideal donor candidates because they have immune cells with memory against SARS-CoV-2. Therefore, the infusion of NK and memory T cells from these donors will increase the pool of cells with cytotoxicity to virally infected cells, and will increase the pool of memory cells that respond quicker to a previously encountered stimulus. This will impact in saving thousands of lives, releasing hospital beds, reducing the costs of a national health system and improving the economy of a locked-down country. Cell therapies are safe and cost-effective and successfully used in other diseases. the investigators need new innovative treatments where others have failed.
Tracking Information
- NCT #
- NCT04578210
- Collaborators
- Universidad Autonoma de Madrid
- Universidad Miguel Hernandez de Elche
- Biocruces Bizkaia Health Research Institute
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Not Provided
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