None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Investigational Product Name: LB-DTK-COV19
Dose: 5x10^6/m^2 (low dose group), 1x10^7/m^2 (intermediate dose group), 2x10^7/m^2 (high dose group)
Frequency: Single
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older at the time of Screening Visit (Visit 1). 2. Individuals confirmed positive for Coronavirus Disease 2019 (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 shall follow the "Guidelines for Laboratory Diagnosis of COVID-19." 3. Hospitalized patients at the time of screening with an oxygen saturation level (SpO2) below 94% in room air (WHO-8 OS stage 4 or 5), who meet one of the following criteria: Require supplemental oxygen therapy, or Require high-flow oxygen therapy, or Require non-invasive ventilation. 4. Female participants, or male participants with female partners, who agree to maintain the following contraception methods during the clinical trial period, and who meet one of the following conditions: The female participant or the female partner of the male participant is postmenopausal (defined as non-therapy-induced amenorrhea for 12 months or more, or as medically confirmed menopause). The female participant or the female partner of the male participant is infertile due to surgical sterilization (e.g., removal of ovaries and/or uterus). Agrees to absolute abstinence during the clinical trial period. (Note: For female participants, intermittent abstinence such as ovulation timing, symptom-based temperature monitoring, or withdrawal methods are not considered as agreeing to abstinence.) If the female participant or the female partner of the male participant is a woman of childbearing potential (WOCBP) who has not undergone sterilization surgery, one of the following contraception methods must be used: Hormonal methods (implant, patch, oral contraceptives). Intrauterine device (IUD). Dual barrier methods (simultaneous use of two methods, such as male condoms, female condoms, cervical caps, diaphragms, or contraceptive sponges). 5. For women of childbearing potential or women less than 12 months post-menopause, a negative pregnancy test (blood test) confirmed at the Screening Visit (Visit 1). 6. Individuals who possess at least one HLA matching the investigational drug in MHC class I. 7. Individuals who can be enrolled within 14 days from the onset of symptoms. 8. Individuals who voluntarily agree to participate in the clinical trial and provide written informed consent, agreeing to comply with the restrictions. 9. Individuals deemed suitable as trial participants based on screening evaluations (e.g., vital signs, physical examination, medical history and surgical history, ECG, and laboratory tests).
Exclusion criteria
Exclusion criteria: 1. Severely ill patients meeting the following criteria: - Requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). - Acute respiratory distress syndrome (ARDS), shock, or multiple organ failure. 2. Uncontrolled pulmonary diseases other than COVID-19 pneumonia (e.g., chronic obstructive pulmonary disease, asthma, cystic fibrosis, tuberculosis, etc.). 3. Patients requiring intubation, mechanical ventilation (WHO 8-OS stage 6), or ECMO (stage 7) at the time of screening. 4. Patients who received treatment within 28 days prior to Screening Visit (Visit 1) with: - Anti-thymocyte globulin (ATG), - Campath, or - Other T cell immunosuppressive monoclonal antibodies. 5. Patients with any of the following conditions based on medical history or screening evaluations: - Uncontrolled hypertension: Systolic BP = 160 mmHg or Diastolic BP = 100 mmHg despite taking antihypertensive medications (measured twice at a minimum interval of 5 minutes). - Uncontrolled diabetes mellitus: 1) Severe hyperglycemia with HbA1c = 10%. 2) History of diabetic ketoacidosis requiring hospitalization within 12 weeks. 3) History of severe hypoglycemia (glucose 5 times the laboratory normal range (LNR)], or chronic kidney disease [Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m²]. 6. 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. 7. Patients requiring vasopressors. 8. Patients with a history of hypersensitivity to T-cell therapy. 9. Patients with a history of autoimmune diseases. 10. Patients with hemophilia or on anticoagulants who are at significant risk of bleeding during injection. 11. Patients who participated in another clinical trial within 24 weeks prior to the administration of the investigational product. 12. Patients with a life expectancy of less than 24 hours at the time of Screening Visit (Visit 1). 13. Other patients deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Countries
Korea, Republic of
Contacts
Public ContactDong Gun Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed