None listed
Conditions
Sponsors
LucasBio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged 19 years or older who have previously undergone myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation using bone marrow, single or double umbilical cord blood, or peripheral blood stem cells (PBSCs). 2. Patients with single or multiple persistent or recurrent cytomegalovirus (CMV), BK virus (BKV), or Epstein Barr virus (EBV) infections despite standard therapy. 3. Patients with single or multiple CMV, EBV, or BKV infections who have failed standard treatment or are intolerant to standard therapy. 4. Patients who can taper steroids to =0.5 mg/kg/day of prednisolone (or equivalent dose). 5. Patients with a hemoglobin level =8.0 g/dL. 6. Patients with evidence of neutrophil engraftment: - Absolute neutrophil count (ANC) =0.5 × 10³/µL maintained for 3 consecutive days. 7. Patients with oxygen saturation (SpO2) =90% on room air. 8. Patients who possess at least one human leukocyte antigen (HLA) allele matching the investigational product at the MHC class I level. 9. Female subjects of childbearing potential or women who have not reached 12 months of postmenopausal amenorrhea must have a negative pregnancy test (serum) at the screening visit (Visit 1). 10. Male or female subjects who agree to use appropriate contraception during the clinical trial, meeting one of the following conditions: - The female subject or the female partner of the male subject is postmenopausal (defined as =12 months of non-therapy-induced amenorrhea or clinically confirmed menopause). - The female subject or the female partner of the male subject is surgically sterile (absence of ovaries and/or uterus). - The subject agrees to remain abstinent during the study. Note: Periodic abstinence methods (e.g., calendar method, symptothermal method, withdrawal) are not acceptable. - If the female subject or the female partner of the male subject is a woman of childbearing potential (WOCBP) who has not undergone sterilization, she must use one of the following: - Hormonal contraception (implant, patch, oral) - Intrauterine device (IUD) - Dual barrier method (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge) 11. Individuals who voluntarily decide to participate in the study and provide written informed consent, agreeing to comply with study requirements. 12. Individuals deemed eligible for participation based on screening assessments (e.g., HLA typing, vital signs, physical examination, medical and surgical history, ECG, and laboratory tests).
Exclusion criteria
Exclusion criteria: 1. Receipt of ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T cell immunosuppressive monoclonal antibody treatment within 28 days prior to the first administration. 2. Any of the following conditions at the time of screening: • Uncontrolled hypertension: Systolic BP =160 mmHg or Diastolic BP =100 mmHg despite antihypertensive therapy. • Uncontrolled diabetes mellitus, defined as: – HbA1c =10.0% – Hospitalization for diabetic ketoacidosis within the past 12 weeks – Emergency treatment or hospitalization within the past 12 weeks due to severe hypoglycemia with seizures or loss of consciousness (glucose 5× ULN) • Chronic kidney disease with eGFR <30 mL/min/1.73m² • Other uncontrolled infections – Patients with bacterial infections must be on antibiotic treatment and show no signs of progression for at least 72 hours prior to enrollment. – Patients with fungal infections must be on systemic antifungal treatment and show no signs of progression for at least 1 week prior to enrollment. 3. Receipt of allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion (DLI) within 28 days prior to screening. 4. Presence of active acute graft-versus-host disease (GvHD) of grade =2. 5. Patients with rapidly progressing malignancy requiring urgent chemotherapy. 6. History of drug abuse within 6 months prior to investigational product administration or suspicion of drug misuse based on interview or physical examination. 7. Patients requiring vasopressor support. 8. History of hypersensitivity to T cell therapy. 9. History of autoimmune disease. 10. Patients with hemophilia or those receiving anticoagulant therapy who are at high risk of severe bleeding during infusion. 11. Receipt of another investigational product within 24 weeks prior to investigational product administration. 12. Life expectancy estimated to be less than 24 hours at the time of screening. 13. Patients under 19 years of age. 14. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment variables (adverse events, vital signs, physical examination, electrocardiogram, laboratory tests);Change in viral load at each time point after administration of the investigational product;Rate of clinical symptom improvement at each time point after administration of the investigational product | — |
Secondary
| Measure | Time frame |
|---|---|
| Multi-virus specific T cell response at each time point after administration of the investigational product compared to baseline;Cytokine profiling at each time point after administration of the investigational product compared to baseline;Immune cell subset analysis at each time point after administration of the investigational product compared to baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactDong Gun Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed