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Tests treatment safety and results for CMV Retinitis
Official title Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.
ClinicalTrials.gov ID: NCT07679412
What this study is testing
What is LB-DTK-CMV?
LB-DTK-CMV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cmv retinitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Patients aged 19 years or older who have been diagnosed with CMV retinitis and have undergone hematopoietic stem cell transplantation or solid organ...
- 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.
You likely can't join if
- Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal...
- 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%
See the full eligibility criteria
- 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...
- 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 people through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc).
- 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%
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.