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Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.

NCT07679412 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-07-01

No results posted yet for this study

Summary

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).

Conditions

  • CMV Retinitis

Interventions

BIOLOGICAL

LB-DTK-CMV

LB-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.

Sponsors & Collaborators

  • LucasBio

    lead INDUSTRY

Principal Investigators

  • Young Hoon Park, MD-PhD · Department of Ophthalmology, The Catholic University of Korea Seoul St.Mary's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-27
Primary Completion
2027-08-14
Completion
2027-08-14

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679412 on ClinicalTrials.gov