CMV RetinitisNCT07679412
Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.
A study testing LB-DTK-CMV in people with CMV Retinitis, run by LucasBio at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- CMV Retinitis
- What is being tested?
- LB-DTK-CMV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2026to 14 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients who are pregnant and able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
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- For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
- Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
- Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc).
Who cannot join
- 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.
- 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%
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- 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.
- Patients who have received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
- Patients with active malignant tumor or uncontrolled recurrence.
- Patients with uncontrolled ophthalmic diseases other than CMV retinitis.
- Female subjects who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods.
- Patients with a life expectancy of less than 24 hours at the time of the screening visit.
- Patients who have received an investigational product from another clinical study within 24 weeks prior to administration of the investigational product in this study.
- Patients deemed ineligible for participation in this clinical study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, 06591
Young Hoon Park, MD-PhD
About this study
Official title: 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?
Read more
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
- Being tested
- LB-DTK-CMV
- Keywords
- CMV, Retinitis, Virus-specific T cells, Antiviral-resistant CMV, Refractory CMV, Hematopoietic Stem Cell Transplantation, Solid Organ Transplantation, Hematologic malignancy, Autoimmune Disease, Immunosuppressants, Immunosuppressive drugs
- Medical subject headings
- Cytomegalovirus Retinitis, Retinitis, Hematologic Neoplasms, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-DTK-CMVBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (All) | Experimental | Not described Receives: Biological: LB-DTK-CMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load
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.
Measured: From screening through 24 weeks after treatment initiation
Clinical Symptom Assessment
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.
Measured: From the screening through 24 weeks after treatment initiation.
Immunogenicity Testing
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.
Measured: From the screening through 24 weeks after treatment initiation.
Adverse Events
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).
Measured: From the baseline visit throughout 24 weeks after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start27 Apr 2026
- Primary completion14 Aug 2027 (estimated)
- Study completion14 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for CMV RetinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LucasBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, YoungHoon Park, The Catholic University of Korea
- Investigators
- Young Hoon Park, MD-PhD, Principal investigator, Department of Ophthalmology, The Catholic University of Korea Seoul St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679412
- Sponsor's protocol ID
- LB-AT-DTK-CMV-RT-AD-CR
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sugar EA, Jabs DA, Ahuja A, Thorne JE, Danis RP, Meinert CL; Studies of the Ocular Complications of AIDS Research Group. Incidence of cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2012 Jun;153(6):1016-24.e5. doi: 10.1016/j.ajo.2011.11.014. Epub 2012 Feb 4.
PubMed 22310076Shamim MM, U.S., Characteristics and Management of Drug-Resistant CMV Retinitis.Ophthalmic Pearls, 2022.
Royston L, Papanicolaou GA, Neofytos D. Refractory/Resistant Cytomegalovirus Infection in Transplant Recipients: An Update. Viruses. 2024 Jul 5;16(7):1085. doi: 10.3390/v16071085.
PubMed 39066247Jabs DA, Enger C, Dunn JP, Forman M. Cytomegalovirus retinitis and viral resistance: ganciclovir resistance. CMV Retinitis and Viral Resistance Study Group. J Infect Dis. 1998 Mar;177(3):770-3. doi: 10.1086/514249.
PubMed 9498461Simmons HZ, Bazzell AF, Dains JE. Adverse Effects of Virus-Specific T-Cell Therapy: An Integrative Review. J Adv Pract Oncol. 2019 Mar;10(2):120-131. Epub 2019 Mar 1.
PubMed 31538024Cruz CR, Hanley PJ, Liu H, Torrano V, Lin YF, Arce JA, Gottschalk S, Savoldo B, Dotti G, Louis CU, Leen AM, Gee AP, Rooney CM, Brenner MK, Bollard CM, Heslop HE. Adverse events following infusion of T cells for adoptive immunotherapy: a 10-year experience. Cytotherapy. 2010 Oct;12(6):743-9. doi: 10.3109/14653241003709686.
PubMed 20429793Khoury R, Grimley MS, Nelson AS, Leemhuis T, Cancelas JA, Cook E, Wang Y, Heyenbruch D, Bollard CM, Keller MD, Hanley PJ, Lutzko C, Pham G, Davies SM, Rubinstein JD. Third-party virus-specific T cells for the treatment of double-stranded DNA viral reactivation and posttransplant lymphoproliferative disease after solid organ transplant. Am J Transplant. 2024 Sep;24(9):1634-1643. doi: 10.1016/j.ajt.2024.04.009. Epub 2024 Apr 19.
PubMed 38643944Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
PubMed 28783452Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.
PubMed 31004020Martits-Chalangari K, Spak CW, Askar M, Killian A, Fisher TL, Atillasoy E, Marshall WL, McNeel D, Miller MD, Mathai SK, Gottlieb RL. ALVR109, an off-the-shelf partially HLA matched SARS-CoV-2-specific T cell therapy, to treat refractory severe COVID-19 pneumonia in a heart transplant patient: Case report. Am J Transplant. 2022 Apr;22(4):1261-1265. doi: 10.1111/ajt.16927. Epub 2021 Dec 27.
PubMed 34910857Vasileiou S, Hill L, Kuvalekar M, Workineh AG, Watanabe A, Velazquez Y, Lulla S, Mooney K, Lapteva N, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Eagar TN, Carrum G, Grimes KA, Leen AM, Lulla P. Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients. Haematologica. 2023 Jul 1;108(7):1840-1850. doi: 10.3324/haematol.2022.281946.
PubMed 36373249Pfeiffer T, Tzannou I, Wu M, Ramos C, Sasa G, Martinez C, Lulla P, Krance RA, Scherer L, Ruderfer D, Naik S, Bocchini C, Fraser IP, Patel B, Ward D, Wang T, Heslop HE, Leen AM, Omer B. Posoleucel, an Allogeneic, Off-the-Shelf Multivirus-Specific T-Cell Therapy, for the Treatment of Refractory Viral Infections in the Post-HCT Setting. Clin Cancer Res. 2023 Jan 17;29(2):324-330. doi: 10.1158/1078-0432.CCR-22-2415.
PubMed 36628536Dadwal SS, Bansal R, Schuster MW, Yared JA, Myers GD, Matzko M, Adnan S, McNeel D, Ma J, Gilmore SA, Vasileiou S, Leen AM, Hill JA, Young JH. Final outcomes from a phase 2 trial of posoleucel in allogeneic hematopoietic cell transplant recipients. Blood Adv. 2024 Sep 10;8(17):4740-4750. doi: 10.1182/bloodadvances.2023011562.
PubMed 38593233Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12.
PubMed 38470444Green A, Rubinstein JD, Grimley M, Pfeiffer T. Virus-Specific T Cells for the Treatment of Systemic Infections Following Allogeneic Hematopoietic Cell and Solid Organ Transplantation. J Pediatric Infect Dis Soc. 2024 Feb 28;13(Supplement_1):S49-S57. doi: 10.1093/jpids/piad077.
PubMed 38417086