The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of allogeneic SARS-CoV-2-Specific T cells (LB-DTK-COV19) in patients with persistent clinical symptoms following a positive SARS-CoV-2 PCR test for 14 days or longer. The main questions it aims to answer are: * What is the maximum tolerated dose of LB-DTK-COV19 based on dose-limiting toxicity? * What treatment emergent adverse events occur following LB-DTK-COV19 infusion? * Does LB-DTK-COV19 result in clinically significant improvement or worsening of clinical symptoms following infusion? Participants will: * Receive a single intravenous infusion of LB-DTK-COV19 (low dose: 5x10\^6/m\^2; mid dose:1x10\^7/m\^2; high dose: 2x10\^7/m\^2). * Attend follow-up visits at the clinic for 6 months after the infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
LB-DTK-COV19 is an allogeneic SARS-CoV-2-specific T cell therapy product derived from third-party donors and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration.
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, South Korea
NCI-CTCAE v5.0 ≥ Grade 3 Rate
The incidence rate of Grade 3 or higher adverse events, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), is assessed to evaluate the safety of LB-DTK-COV19. Grade 3-5 adverse events include severe or medically significant, life-threatening, and fatal adverse events.
Time frame: From baseline visit through 24 weeks after treatment initiation.
Adverse Events
The investigator must confirm the occurrence of adverse events through medical examinations, including interviews and medical history reviews, during regular visits throughout the clinical trial period. Adverse events shall be assessed at each visit starting from the administration of the investigational drug at the baseline visit.
Time frame: From the baseline visit through 24 weeks after treatment initiation.
Disease Progression Rate
Proportion of patients with disease progression (defined as the need for mechanical ventilation, extracorporeal membrane oxygenation \[ECMO\], or death) at 1 month following LB-DTK-COV19 administration.
Time frame: From the screening visit through 24 weeks after treatment initiation.
WHO Ordinal Scale
The time to improvement in the World Health Organization (WHO) Ordinal Scale, defined as an improvement of at least 1 point from baseline, will be assessed. The WHO Ordinal Scale ranges from 0 (uninfected, with no viral RNA detected) to 10 (death), with higher scores indicating greater disease severity. The outcome is summarized by both the time to improvement and the proportion of participants achieving the improvement by four weeks following LB-DTK-COV19 infusion.
Time frame: From the screening visit through 24 weeks after treatment initiation.
NEWS2 Score
The time to achievement of a National Early Warning Score 2 (NEWS2) of 0 sustained for at least 24 hours is assessed. The NEWS2 score ranges from 0 (requiring routine monitoring) to 20 (emergent transport to hospital), with higher scores indicating greater degree of illness of a patient. The outcome is summarized by both the time to achievement and the proportion of participants achieving the endpoint by four weeks following LB-DTK-COV19 infusion.
Time frame: From the screening visit through 24 weeks after treatment initiation.
Viral load
Nasopharyngeal swab samples were used for PCR testing to assess SARS-CoV-2 viral load.
Time frame: From the screening visit through 24 weeks after treatment initiation.
SARS-CoV2-Specific T-cell Responses
SARS-CoV2-specific T-cell responses are assessed using IFN-γ ELISPOT assay and spot-forming units.
Time frame: From the screening visit through 24 weeks after treatment initiation.
Characterization of SARS-CoV-2-Specific T cells
SARS-CoV-2-specific T cell subsets are characterized using flow cytometry.
Time frame: From the screening visit through 24 weeks after treatment initiation.
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