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Personalized immune cells take aim at Drug-Resistant eye virus

NCT ID NCT07679412

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new treatment called LB-DTK-CMV for people with cytomegalovirus (CMV) retinitis that has not responded to standard antiviral medicines. The treatment uses a patient's own immune cells, specially trained to attack CMV, and is given as two infusions. The trial aims to see if this approach is safe and can reduce the virus in the eye and blood, as well as improve vision-related symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LB-DTK-CMV (a personalized T-cell therapy made from the patient's own immune cells)
What this could lead to
If it works, this could offer a new treatment option for people with CMV retinitis that does not respond to standard antiviral drugs.
What could go wrong
This is a very early, small study with only 5 participants, so results may not apply to everyone. The therapy involves infusions that could cause side effects or fail to control the infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Catholic University of Korea Seoul St.Mary's Hospital

    RECRUITING

    Seoul, 06591, South Korea

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