Autologous LB-DTK-CMV cells for antiviral-resistant CMV retinitis in transplant/immune-suppressed patients
Official title: An Exploratory Clinical Study of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.
Run by LucasBio · NCT07679412 · Data updated 2026-11-12
This trial tests whether a patient’s own CMV-specific T cells (LB-DTK-CMV) can safely improve CMV retinitis in people with antiviral-resistant disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | LucasBio Industry-sponsored |
| Drugs / interventions | Alemtuzumab |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | April 27, 2026 |
| Main results expected | August 14, 2027 |
| Study ends | August 14, 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07679412 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with CMV retinitis who are transplant recipients or on high-level immunosuppression and have antiviral-resistant or refractory disease.
✕Probably not a fit
Patients whose CMV retinitis does not respond to LB-DTK-CMV or who experience intolerable adverse events may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an exploratory interventional study evaluating the safety and potential efficacy of autologous CMV-specific T cells (LB-DTK-CMV) in adults with antiviral-resistant or refractory CMV retinitis. Participants receive two infusions at two-week intervals, a three-week rest, then two more infusions, to see if treatment reduces CMV levels in plasma and eye fluids and improves clinical symptoms. Primary questions focus on adverse events, duration of efficacy, and clinically meaningful reductions in CMV viral load and symptoms. The study is conducted at a single center with LucasBio as lead sponsor.
Why it matters
Potential benefit: If successful, patients may experience fewer CMV-related eye problems and a reduction in viral load, potentially preserving vision.
How similar studies have gone: Prior research with CMV-specific T cells in other CMV-related conditions has shown potential safety and hints of efficacy, but this approach for CMV retinitis is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Young Hoon Park, MD-PhD — Department of Ophthalmology, The Catholic University of Korea Seoul St.Mary's Hospital
- Study coordinator: Nayoun Kim, Ph.D.
- Email: nkim@lucasbio.com
- Phone: +82 1040222340
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.