Evaluation of the Safety and Efficacy of Autologous COVID-19 Antigen Specific T Cell in Prolonged SARS-CoV-2 Patients

NCT07690943 | Completed

• 1 other identifier: LB-AT-DTK-COV19-AD-CR
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to evaluate the safety and efficacy of autologous COVID-19 antigen specific T cell (LB-DTK-COV19) treatment in prolonged SARS-CoV-2 infected patients. The main questions it aims to answer are:

• What adverse events occur after the infusion of LB-DTK-COV19?
• Is there a clinically significant improvement in clinical symptoms within 4 weeks after the infusion?
• Is there a clinically significant reduction in SARS-CoV-2 viral load within 4 weeks after the infusion? The patients will:
• Receive a single infusion of LB-DTK-COV19 either intravenously or using central venous catheter during the baseline visit at a dose of 1x10\^7/m\^2.
• Receive a second infusion of LB-DTK-COV19 either intravenously or using central venous catheter at the same dose 14 days after the first infusion.
• Attend follow-up visits at the clinic for 6 months after the first infusion.

Conditions

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

Keywords

SARS-CoV-2 Infection; Infections; Virus Diseases; T-lymphocytes; Immunocompromised host; Adoptive transfer

Outcome Measures

Primary Outcomes (7)

• Viral load

  Nasopharyngeal swab samples were used for PCR testing and ELISA to assess SARS-CoV-2 viral load and immunoglobulin levels.

  From the screening visit through 24 weeks after treatment initiation.

• WHO Ordinal Scale

  The time to improvement in the WHO Ordinal Scale, defined as an improvement of at least 1 point from baseline, is assessed. 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 NEWS2 score of 0 sustained for at least 24 hours is assessed. 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.

• Chest CT Severity Score

  Proportion of patients with improvement in chest CT severity scores at four weeks following LB-DTK-COV19 infusion is measured.

  From the screening visit through 24 weeks after treatment initiation.

• Quantification of SARS-CoV-2-Specific T cells

  SARS-CoV-2-specific T cells and their subsets are quantified using flow cytometry.

  From the baseline 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 baseline through 24 weeks after treatment initiation.

• Adverse Events

  The investigator must confirm the occurrence of adverse events through medical examinations during regular visits throughout the clinical study 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.

Study Arms (1)

LB-DTK-COV19

EXPERIMENTAL

Biological: LB-DTK-COV19

Interventions

LB-DTK-COV19 BIOLOGICAL

\- LB-DTK-COV19 is an autologous SARS-CoV-2-specific T cell therapy product derived from a patient 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:

• Patients aged 19 years or older.
• Patients who tested positive for COVID-19 RT-PCR with persistent COVID-19 symptoms and experienced initial symptoms or received a first COVID-19 diagnosis more than 21 days prior to treatment.
• Given that LB-DTK-COV19 requires 21 days to manufacture, patients who experienced initial symptoms or received a first COVID-19 diagnosis more than 7 days prior to screening may be eligible for enrollment. Following registration, COVID-19 RT-PCR positivity will be reassessed 21 days later. Eligible patients with confirmed positive COVID-19 test results will receive the study product infusion. Patients who test negative for COVID-19 will be withdrawn from the study.
• Patients with a life expectancy longer than 3 months.
• Patients who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.

You may not qualify if:

• Critically ill patients (WHO ordinal scale, category 7 or higher) who meet any of the following criteria:
• Require invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
• Diagnosed with acute respiratory distress syndrome (ARDS), shock, or multiple organ failure.
• Patients with lung diseases other than COVID-19 pneumonia (including chronic obstructive pulmonary disease, asthma, cystic lung disease, tuberculosis, etc)
• Female subjects who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods.
• Patients with active infection or fever (≥38°C) of unknown etiology, or ongoing bacterial or fungal infection.
• Patients aged less than 19 years.
• Patients who have been diagnosed with HIV, uncontrollable hypertension, unstable angina, congestive heart failure (NY class II or higher), uncontrollable severe diabetes, coronary angioplasty within the past 6 months, acute myocardial infarction or non-malignant disease, including uncontrollable atrial or ventricular fibrillation, within the past 6 months.
• Uncontrollable hypertension is defined as Systolic BP ≥160 mmHg or Diastolic BP ≥100 mmHg despite taking blood pressure medications.
• 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 mental illness or drug intoxication that may affect the results of this clinical study.
• Patients who are participating in another clinical study.

Sponsors & Collaborators

• LucasBio: lead

Study Sites (1)

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

Seoul, 06591, South Korea

Location

Related Publications (11)

• Kim N, Lee JM, Oh EJ, Jekarl DW, Lee DG, Im KI, Cho SG. Off-the-Shelf Partial HLA Matching SARS-CoV-2 Antigen Specific T Cell Therapy: A New Possibility for COVID-19 Treatment. Front Immunol. 2021 Dec 23;12:751869. doi: 10.3389/fimmu.2021.751869. eCollection 2021.

  PMID: 35003063 BACKGROUND

• Basar R, Uprety N, Ensley E, Daher M, Klein K, Martinez F, Aung F, Shanley M, Hu B, Gokdemir E, Nunez Cortes AK, Mendt M, Reyes Silva F, Acharya S, Laskowski T, Muniz-Feliciano L, Banerjee PP, Li Y, Li S, Melo Garcia L, Lin P, Shaim H, Yates SG, Marin D, Kaur I, Rao S, Mak D, Lin A, Miao Q, Dou J, Chen K, Champlin RE, Shpall EJ, Rezvani K. Generation of glucocorticoid-resistant SARS-CoV-2 T cells for adoptive cell therapy. Cell Rep. 2021 Jul 20;36(3):109432. doi: 10.1016/j.celrep.2021.109432. Epub 2021 Jul 7.

  PMID: 34270918 BACKGROUND

• Keller MD, Harris KM, Jensen-Wachspress MA, Kankate VV, Lang H, Lazarski CA, Durkee-Shock J, Lee PH, Chaudhry K, Webber K, Datar A, Terpilowski M, Reynolds EK, Stevenson EM, Val S, Shancer Z, Zhang N, Ulrey R, Ekanem U, Stanojevic M, Geiger A, Liang H, Hoq F, Abraham AA, Hanley PJ, Cruz CR, Ferrer K, Dropulic L, Gangler K, Burbelo PD, Jones RB, Cohen JI, Bollard CM. SARS-CoV-2-specific T cells are rapidly expanded for therapeutic use and target conserved regions of the membrane protein. Blood. 2020 Dec 17;136(25):2905-2917. doi: 10.1182/blood.2020008488.

  PMID: 33331927 BACKGROUND

• Cooper RS, Fraser AR, Smith L, Burgoyne P, Imlach SN, Jarvis LM, Turner DM, Zahra S, Turner ML, Campbell JDM. Rapid GMP-Compliant Expansion of SARS-CoV-2-Specific T Cells From Convalescent Donors for Use as an Allogeneic Cell Therapy for COVID-19. Front Immunol. 2021 Jan 8;11:598402. doi: 10.3389/fimmu.2020.598402. eCollection 2020.

  PMID: 33488592 BACKGROUND

• Ferreras C, Pascual-Miguel B, Mestre-Duran C, Navarro-Zapata A, Clares-Villa L, Martin-Cortazar C, De Paz R, Marcos A, Vicario JL, Balas A, Garcia-Sanchez F, Eguizabal C, Solano C, Mora-Rillo M, Soria B, Perez-Martinez A. SARS-CoV-2-Specific Memory T Lymphocytes From COVID-19 Convalescent Donors: Identification, Biobanking, and Large-Scale Production for Adoptive Cell Therapy. Front Cell Dev Biol. 2021 Feb 25;9:620730. doi: 10.3389/fcell.2021.620730. eCollection 2021.

  PMID: 33718360 BACKGROUND

• Guerreiro M, Aguilar-Gallardo C, Montoro J, Frances-Gomez C, Latorre V, Luna I, Planelles D, Carrasco MP, Gomez MD, Gonzalez-Barbera EM, Aguado C, Sempere A, Solves P, Gomez-Segui I, Balaguer-Rosello A, Louro A, Perla A, Larrea L, Sanz J, Arbona C, de la Rubia J, Geller R, Sanz MA, Sanz G, Luis Pinana J. Adoptive transfer of ex vivo expanded SARS-CoV-2-specific cytotoxic lymphocytes: A viable strategy for COVID-19 immunosuppressed patients? Transpl Infect Dis. 2021 Aug;23(4):e13602. doi: 10.1111/tid.13602. Epub 2021 Mar 31.

  PMID: 33728702 BACKGROUND

• Papayanni PG, Chasiotis D, Koukoulias K, Georgakopoulou A, Iatrou A, Gavriilaki E, Giannaki C, Bitzani M, Geka E, Tasioudis P, Chloros D, Fylaktou A, Kioumis I, Triantafyllidou M, Dimou-Besikli S, Karavalakis G, Boutou AK, Siotou E, Anagnostopoulos A, Papadopoulou A, Yannaki E. Vaccinated and Convalescent Donor-Derived Severe Acute Respiratory Syndrome Coronavirus 2-Specific T Cells as Adoptive Immunotherapy for High-Risk Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 Dec 6;73(11):2073-2082. doi: 10.1093/cid/ciab371.

  PMID: 33905481 BACKGROUND

• 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.

  PMID: 34405140 BACKGROUND

• Martits-Chalangari K, Spak CW, Askar M, Killian A, Fisher TL, Atillasoy E, Marshall WL, McNeel D, Miller MD, Mathai SK, Gottlieb RL. ALVR109, an off-the-shelf partially HLA matched SARS-CoV-2-specific T cell therapy, to treat refractory severe COVID-19 pneumonia in a heart transplant patient: Case report. Am J Transplant. 2022 Apr;22(4):1261-1265. doi: 10.1111/ajt.16927. Epub 2021 Dec 27.

  PMID: 34910857 BACKGROUND

• Lee CY, Shah MK, Hoyos D, Solovyov A, Douglas M, Taur Y, Maslak P, Babady NE, Greenbaum B, Kamboj M, Vardhana SA. Prolonged SARS-CoV-2 Infection in Patients with Lymphoid Malignancies. Cancer Discov. 2022 Jan;12(1):62-73. doi: 10.1158/2159-8290.CD-21-1033. Epub 2021 Nov 9.

  PMID: 34753749 BACKGROUND

• Lee R, Kim N, Kim WB, Im KI, Nho D, Cho SY, Park C, Beck KS, Lee G, Lee I, Cho SG, Lee DG. Effectiveness and Safety of Autologous Virus-Specific T-Cell Therapy for Persistent COVID-19 in People With Immunocompromise: A Clinical Trial Study. Clin Infect Dis. 2026 Feb 4;81(6):e510-e514. doi: 10.1093/cid/ciaf302.

  PMID: 40493744 RESULT

MeSH Terms

Conditions

COVID-19; Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rae Seok 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: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Infectious Disease

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 8, 2026
• Study Start: June 8, 2023
• Primary Completion: May 31, 2024
• Study Completion: January 22, 2025
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)