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%
LucasBio
Lead sponsor
The Catholic University of Korea
Sponsor institution