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

Korábbi kezelés

• 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 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 with hemophilia or receiving anticoagulant therapy who are at significant risk of bleeding during injection.
• Patients who participated in another clinical study within 24 weeks prior to the administration of the investigational product.

Más betegség

• 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 with a history of hypersensitivity to T-cell therapy.
• Patients with a history of autoimmune diseases.

Laborértékek

• 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

Egyéb

• Patients requiring intubation, mechanical ventilation (WHO 8-OS stage 6), or ECMO (stage 7) at the time of screening.
• Patients who require vasopressors.
• Patients with a life expectancy of less than 24 hours at the time of screening.
• Other patients deemed unsuitable for participation in this clinical trial by the investigator.

• 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
  • Administered CD20 inhibitor in the past 1 year
  • Hematologic malignancies (ex. CLL, MM, NHL, etc)
  • Undergone hematopoietic stem cell transplantation or GVHD treatment in the past 1 year
  • Undergone CAR-T therapy
  • Solid organ transplant patients
  • Primary hypogammaglobulinemia
  • Other severe primary or acquired immunodeficiency
• 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 criteria:
  • 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 (ex. removal of ovaries and/or uterus)
  • Agrees to absolute abstinence during the clinical trial period [For female participants, intermittent abstinence (ex. ovulation timing, symptom-based temperature monitoring, or withdrawal methods) is 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
  • Dual barrier methods (simultaneous use of two methods, such as male condoms, female condoms, cervical caps, diaphragms, or contraceptive sponges)
• For women of childbearing potential or women who are less than 12 months postmenopausal, a negative pregnancy test (blood test) confirmed at the screening visit.
• Individuals who have at least one HLA match with the investigational drug in MHC class I.
• Individuals who voluntarily agree to participate in this clinical trial and provide written consent to comply with the restrictions.
• Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc).