None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Investigational Medicinal Product (IMP) Name: Autologous Cytomegalovirus (CMV)-specific T cells: LB-DTK-CMV
Dose: 2 × 107 cells/m² (two times ten to the seventh cells p
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged 19 years or older with a diagnosis of cytomegalovirus (CMV) retinitis, who have undergone cancer treatment (e.g., chemotherapy, hematopoietic stem cell transplant), solid organ transplant, or are receiving high-dose immunosuppressive therapy for autoimmune disease, and have one of the following conditions:Persistent or progressive CMV retinitis despite systemic or intravitreal antiviral treatment.Ongoing CMV viremia or new-onset CMV retinitis despite systemic antiviral treatment.Confirmed CMV UL54 or UL97 mutation conferring antiviral resistance.Intolerance or toxicity to one or more systemic antiviral agents. 2.Patients whose clinical condition can tolerate a reduction of steroids to \(0.5\text{\ mg/kg/day}\) Prednisolone (or equivalent). 3.Females of childbearing potential must have a negative pregnancy test (blood test) at the screening visit. 4.Patients who voluntarily agree to participate in this clinical study and provide written consent to comply with the restrictions. 5.Patients deemed eligible by screening assessments (vital signs, physical examination, medical and surgical history, ECG, laboratory tests, etc.)
Exclusion criteria
Exclusion criteria: 1.Patients who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose of the study drug. 2. Patients who meet any of the following criteria at the time of screening : Uncontrolled hypertension: Systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg despite the use of antihypertensive medication. Uncontrolled severe diabetes mellitus: Defined as: Severe hyperglycemia with HbA1c > 10.0%. History of hospitalization for diabetic ketoacidosis within the past 12 weeks. History of receiving emergency treatment or hospitalization for severe hypoglycemia (glucose 5 times the upper limit of normal (ULN). Chronic kidney disease: Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m² . Other uncontrolled infections. However, the following cases are considered controlled infections and are not subject to this exclusion criterion: Bacterial infections: Patients must be receiving antibiotic treatment for the infection and have no signs of infection progression for 72 hours prior to study enrollment. Fungal infections: Patients must be receiving systemic antifungal treatment and have no signs of infection progression for 1 week prior to study enrollment. 3. Patients who have undergone allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion (DLI) within 28 days prior to the first dose of the study drug 4. Patients with active malignancy or uncontrolled recurrence. 5. Patients with uncontrolled ophthalmic diseases other than cytomegalovirus retinitis. 6. Pregnant or breastfeeding women, or women of childbearing potential who are not using adequate contraceptive measures. 7. Patients with an expected life expectancy of less than 24 hours at the time of screening. 8. Patients who have received other investigational medicinal products within 24 weeks prior to the administration of the study drug. 9. Patients whom the investigator determines unsuitable for participation in this clinical 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;Immune cell subset analysis at each time point after administration of the investigational product compared to baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Hoon Park
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed