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

June 25, 2026 updated by: YoungHoon Park, LucasBio

An Exploratory Clinical Study of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea Seoul St.Mary's Hospital
        • Principal Investigator:
          • Young Hoon Park, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 19 years or older who have been diagnosed with CMV retinitis and have undergone hematopoietic stem cell transplantation or solid organ transplantation for the treatment of hematologic malignancies, or have received high-dose immunosuppressive therapy for the treatment of autoimmune diseases, and who meet at least one of the following criteria:

    • 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.
  2. Patients who are pregnant and able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
  3. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
  4. Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
  5. Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc).

Exclusion Criteria:

  1. 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.

  2. Individuals who meet any of the following criteria at the time of screening:

    • Uncontrolled hypertension

      • Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.

    • Uncontrolled severe diabetes: Severe diabetes is defined as follows:

      • Severe hyperglycemia with HbA1C ≥ 10.0%
      • Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks.
      • Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose <54 mg/dL) accompanied by seizures and loss of consciousness.

    • Other viral infections

      • Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
      • However, patients who are tested negative for HBsAg and positive for Anti-HBcAb are not subject to this exclusion criterion.
    • Tuberculosis
    • Syphilis

    • Moderate or severe liver damage

      • Aspartate aminotransferase (AST) or Alanin aminotransferase (ALT) > 5 times the upper limit of normal (ULN)

    • Chronic kidney disease

      • eGFR < 30mL/min/1.73m^2

    • Other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria:

      • Bacterial infection: Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical study.
      • Fungal infection: Patients must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical study.
  3. Patients who have received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
  4. Patients with active malignant tumor or uncontrolled recurrence.
  5. Patients with uncontrolled ophthalmic diseases other than CMV retinitis.
  6. Female subjects who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods.
  7. Patients with a life expectancy of less than 24 hours at the time of the screening visit.
  8. Patients who have received an investigational product from another clinical study within 24 weeks prior to administration of the investigational product in this study.
  9. Patients deemed ineligible for participation in this clinical study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (All)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral Load
Time Frame: From screening through 24 weeks after treatment initiation
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.
From screening through 24 weeks after treatment initiation
Clinical Symptom Assessment
Time Frame: From the screening through 24 weeks after treatment initiation.
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.
From the screening through 24 weeks after treatment initiation.
Immunogenicity Testing
Time Frame: From the screening through 24 weeks after treatment initiation.
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.
From the screening through 24 weeks after treatment initiation.
Adverse Events
Time Frame: From the baseline visit throughout 24 weeks after treatment initiation.
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).
From the baseline visit throughout 24 weeks after treatment initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LucasBio

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2026

Primary Completion (Estimated)

August 14, 2027

Study Completion (Estimated)

August 14, 2027

Study Registration Dates

First Submitted

June 25, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB-AT-DTK-CMV-RT-AD-CR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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