Genetically Engineered T-Cells for Viral Infections in Cancer Patients
This study is testing a new treatment called Virus-specific Cytotoxic T-lymphocytes (CTLs) for cancer patients with certain viral infections. These CTLs are special immune cells that have been genetically changed to specifically target and kill viruses like adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19. These infections can be very serious for cancer patients, especially after a stem cell transplant. The study aims to see if giving these genetically modified CTLs intravenously (through a vein) is safe and helps control these infections. We're also looking at how well the treatment works and if the cells stay in your body. This study plans to enroll 30 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
- What's involved
- You would receive Virus-specific CTLs intravenously. You might receive up to 8 additional infusions, at least two weeks apart, if needed.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will be followed up yearly for 15 years.
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NCT05101213
Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients
Terminated
PHASE1Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~12 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Virus-specific Cytotoxic T-lymphocytes
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of administering genetically engineered glucocorticoid receptor knock out virus specific cytotoxic T-lymphocyte (CTL) lines, as indicated by Overall Survival
Measured over through study completion, an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- May Daher, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients \> or = 18 years of age or older.
For BKV, ADV or CMV infections: Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cells or single or double umbilical cord blood. For JC virus and COVID19 infection: no prior hematopoietic stem cell transplantation (HSCT) is required.
For BKV infection, patients need to have polymerase chain reaction (PCR) positive for BKV (in peripheral blood or urine) with consistent clinical symptoms.
For ADV infection, patients need to have PCR positive for ADV in peripheral blood AND/OR patients need to fit criteria of probable or definitive adenovirus organ disease.
For CMV infection, patients need to have PCR positive for CMV in peripheral blood AND/OR patients need to fit criteria of probable or definitive CMV disease.
For JCV, patients need to have documented JC viral encephalitis or JC end-organ disease.
For COVID-19 infection, patients need to have COVID-19 related pneumonia/acute respiratory distress syndrome (ARDS) to be enrolled, defined as patients with a positive COVID-19 test (bronchoalveolar lavage \[BAL\], nasal or pharyngeal) and radiological and clinical signs of pneumonia or ARDS.
Written informed consent from patient or designated power of attorney.
Subjects are also are required to consent to PA17-0483 for long term follow up per the guidelines set forth by the Food and Drug Administrations' (FDA's) Biologic Response Modifiers Advisory Committee (BRMAC).
Negative pregnancy blood test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use at least two forms of birth control during the study and for at least 6 months after stopping treatment. Acceptable forms of birth control include intrauterine device (IUD), hormonal methods (birth control pills, injections, and implants), condoms, diaphragms, tubal ligation, or vasectomy.
Exclusion
Patients who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or campath within 28 days of enrollment.
Patients with other uncontrolled infections (excluding human immunodeficiency virus \[HIV\]/acquired immunodeficiency syndrome \[AIDS\]). For bacterial infections, patients must be receiving definitive therapy and have signs of improving infection prior to enrollment as determined by the principal investigator (PI). For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have signs of improving infection prior to enrollment as determined by the PI.
Patients with active steroid refractory graft versus host disease (GVHD).
Patients on immunosuppressive therapy other than tacrolimus, sirolimus or steroids
Active and uncontrolled relapse of malignancy. Patients with controlled malignancy on maintenance therapy would be eligible for the study.
What this trial measures
- Feasibility of administering genetically engineered glucocorticoid receptor knock out virus specific cytotoxic T-lymphocyte (CTL) lines, as indicated by Overall Survivalthrough study completion, an average of 1 year