Evaluation of Safety, Tolerance, and Efficacy of Allogeneic LB-DTK-COV19 in Severe Coronavirus Disease 2019 Patients

NCT07709637 | Active Not Recruiting Phase 1

• 1 other identifier: LB-CL-PB-DTK-COV19-002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; COVID-19 (SARS-CoV-2 Infection)

Keywords

SARS-CoV-2 Infection; Infections; Virus Diseases; Respiratory Symptoms; Hematopoietic Stem Cell Transplantation; Immunocompromised host; Pneumonia; Hematologic Malignancies

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From the screening visit through 24 weeks after treatment initiation.

Study Arms (1)

LB-DTK-COV19

EXPERIMENTAL

Biological: LB-DTK-COV19

Interventions

LB-DTK-COV19 BIOLOGICAL

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.

LB-DTK-COV19

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older at the time of screening (Visit 1).
• Individuals confirmed positive for COVID-19 by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) testing. If the test was conducted more than 10 days prior to the screening date, retesting is required for enrollment. The testing criteria follow the "Guidelines for Laboratory Diagnosis of COVID-19".
• Individuals who have received treatment with two or more antiviral drugs.
• Patients who are refractory to standard-of-care.
• Individuals who meet all the following criteria of persistent COVID-19:
• Viral Criteria: Positive COVID-19 PCR test results persisting for more than 14 days after the initial positive test
• Clinical Criteria: Individuals with two or more of the following symptoms for 14 days or more either intermittently or continuously
• Fever
• Fatigue
• Respiratory symptoms
• Weight loss
• Diarrhea
• Increase in inflammatory markers
• Imaging Criteria: Clinically significant change in lung parenchyma based on chest CT.
• Medical History Criteria: Individuals who meet any of the following criteria

You may not qualify if:

• Severely ill patients who meet the following criteria:
• Requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
• Acute respiratory distress syndrome (ARDS), shock, or multiple organ failure
• Uncontrolled pulmonary diseases other than COVID-19 pneumonia (ex. chronic obstructive pulmonary disease, asthma, cystic fibrosis, tuberculosis, etc.)
• Patients requiring intubation, mechanical ventilation (WHO 8-OS stage 6), or ECMO (stage 7) at the time of screening.
• Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath, or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the screening visit.
• Patients with uncontrollable hypertension, uncontrollable diabetes, other viral infections (ex. Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), etc), syphilis, refractory malignancy, moderate or severe liver damage \[Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 5 Lab normal range (LNR)\], or chronic kidney diseases (estimated Glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2) based on medical history or at the time of screening.
• Uncontrollable hypertension is defined as Systolic BP ≥160mmHg or Diastolic BP ≥100 mmHg despite taking blood pressure medications (Up to 3 measurements with a minimum interval of 5 minutes)
• Severe diabetes is defined as follows:
• Severe hyperglycemia with HbA1c ≥ 10.0%
• Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks
• Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose \< 54mg/dL) accompanied by seizures and loss of consciousness
• Patients with a history of substance abuse within 6 months prior to the administration of the investigational product, or those suspected of taking drugs prone to misuse based on medical interviews and physical examinations.
• Patients who require vasopressors.
• Patients with a history of hypersensitivity to T-cell therapy.

Sponsors & Collaborators

• LucasBio: lead

Study Sites (1)

The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, 06591, South Korea

Location

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MeSH Terms

Conditions

COVID-19; Infections; Virus Diseases; Signs and Symptoms, Respiratory; Pneumonia; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dong-Gun Lee, MD-PhD

  Department of Infectious Disease, The Catholic University of Korea Seoul St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: July 31, 2025
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)