Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating genetically modified cytotoxic T-lymphocytes (CTLs) designed to target infections caused by adenovirus, BK virus, cytomegalovirus, JC virus, or COVID-19 in immunocompromised cancer patients. This phase I trial aims to test the feasibility and safety of these virus-specific CTLs in controlling viral infections, which are a serious cause of illness and death after hematopoietic stem cell transplantation. The study also seeks preliminary data on treatment efficacy, cell persistence, and survival outcomes. Participants receive virus-specific CTLs through an intravenous infusion over 30 minutes. Depending on their response—partial, stable, or progressive disease—they may receive up to eight additional infusions spaced at least two weeks apart. After completing treatment, patients are monitored with yearly follow-ups for 15 years to assess long-term effects and outcomes. During the study, patients undergo evaluations including viral testing, clinical assessments, and monitoring of overall survival as the primary outcome. Researchers track the persistence of the infused cells and gather data on relapse-free and overall survival. The long-term follow-up period ensures ongoing observation of safety and durability of the treatment effects, with total participation potentially spanning many years.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Prior allogeneic hematopoietic stem cell transplant for BKV, ADV, or CMV infections
- PCR positive for BKV with clinical symptoms for BKV infection
- PCR positive for adenovirus or meeting criteria for adenovirus organ disease for ADV infection
- PCR positive for CMV or meeting criteria for CMV disease for CMV infection
- Documented JC viral encephalitis or end-organ disease for JCV infection
- Positive COVID-19 test with pneumonia or ARDS for COVID-19 infection
- Written informed consent from patient or designated power of attorney
- Consent to long-term follow-up per FDA guidelines
- Negative pregnancy test and use of two forms of birth control for women of childbearing potential
You will not qualify if you...
- Receipt of anti-thymocyte globulin within 14 days or donor lymphocyte infusion or campath within 28 days of enrollment
- Presence of uncontrolled infections except HIV/AIDS
- Active steroid refractory graft versus host disease
- Use of immunosuppressive therapy other than tacrolimus, sirolimus, or steroids
- Active and uncontrolled relapse of malignancy
- Patients with controlled malignancy on maintenance therapy are eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 16 weeks depending on number of infusions
Participants receive genetically engineered virus-specific cytotoxic T-lymphocytes intravenously over 30 minutes. Depending on their response, they may receive up to 8 additional infusions spaced at least 2 weeks apart.
1 initial infusion visit and up to 8 additional infusion visits spaced at least 2 weeks apart
Duration - Up to 15 years
After completing treatment, participants are followed up yearly to assess long-term outcomes including survival and relapse.
Yearly visits for up to 15 years
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
May Daher, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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