The goal of this exploratory clinical study is to evaluate the safety and efficacy of Cytomegalovirus-Specific T cells (LB-DTK-CMV) to treat patients diagnosed with antiviral-resistant and refractory cytomegalovirus retinitis. The main questions it aims to answer are:
* What adverse events occur after the infusion of LB-DTK-CMV? * What is the duration of efficacy following treatment? * Is there a clinically significant reduction in CMV viral load in plasma and aqueous humor after the infusion? * Is there a clinically significant improvement in clinical symptoms after the infusion?
Participants will:
* Receive two infusions of LB-DTK-CMV at 2x10\^7cells/m\^2 at two-week intervals beginning at the baseline visit (Cycle 1). * Take a three-week resting period following completion of Cycle 1. * Receive two infusions of LB-DTK-CMV at 2x10\^7cells/m\^2 at two-week intervals beginning three weeks after the last dose of Cycle 1 (Cycle 2).
Patients with persistent or progressive CMV retinitis despite systemic antiviral therapy or intravitreal antiviral treatment.
Patients who have showed persistent CMV viremia despite systemic antiviral therapy or developed new CMV retinitis.
Patients with CMV UL54 or UL97 mutations associated with antiviral resistance.
Patients with adverse effects or toxicities limiting the administration of more than one systemic antiviral drug.
Individuals 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.
Uncontrolled hypertension
Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.
Severe hyperglycemia with HbA1C ≥ 10.0%
Single group
LB-DTK-CMV
Biological/VaccineLB-DTK-CMV is a CMV-specific T cell therapy product derived from a patient (autologous) and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration.
Viral Load
CMV viral load testing is performed using plasma and aqueous humor samples. Viral load is measured at the screening visit and weekly for the first 4 weeks after the first dose in Cycle 1 through the resting period, followed by two measurements at 2-week intervals, then once every 4 weeks, and subsequently once every 12 weeks.
Clinical Symptom Assessment
Clinical symptom assessments include visual acuity test, fundus examination, and optical coherence tomography. However, optical coherence tomography only applies to patients diagnosed with CMV retinitis involving the central retina. Fluorescein angiography (FAG) may also be performed on Visit 1 and 11 if considered necessary by the investigator.
Immunogenicity Testing
Immunogenicity testing using IFN-γ ELISpot assay is performed to quantify CMV-specific T cells and evaluate the persistence and reconstitution of the immune response.
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 (Visit 3).
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LucasBio
Lead sponsor
The Catholic University of Korea
Sponsor institution
