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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

• 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).

Locations
Other Locations
Republic of Korea
The Catholic University of Korea Seoul St.Mary's Hospital
RECRUITING
Seoul
Contact Information
Primary
Nayoun Kim, Ph.D.
nkim@lucasbio.com
+82 1040222340
Time Frame
Start Date: 2026-04-27
Estimated Completion Date: 2027-08-14
Participants
Target number of participants: 5
Treatments
Experimental: Experimental Group (All)
Sponsors
Leads: LucasBio

This content was sourced from clinicaltrials.gov

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