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
212 weeks
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
This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic options for these infections are often complicated by associated toxicities. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. Depending on which virus a patient is infected with (ADV, BKV, CMV, JCV, or COVID-19), the CTLs will be designed to specifically attack that virus. Giving genetically modified CTLs may help to control the infection.
CONDITIONS
Official 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.
- For BK virus, adenovirus, or cytomegalovirus infections: prior allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cells, or umbilical cord blood.
- For JC virus and COVID-19 infection: no prior hematopoietic stem cell transplant required.
- For BK virus infection: positive PCR test in blood or urine with consistent clinical symptoms.
- For adenovirus infection: positive PCR test in blood and/or criteria for probable or definitive adenovirus organ disease.
- For cytomegalovirus infection: positive PCR test in blood and/or criteria for probable or definitive cytomegalovirus disease.
- For JC virus infection: documented JC viral encephalitis or JC end-organ disease.
- For COVID-19 infection: pneumonia or acute respiratory distress syndrome with positive test and clinical signs.
- Written informed consent from patient or power of attorney.
- Consent for long-term follow-up per FDA guidelines.
- Negative pregnancy test for women of childbearing potential and agreement to use two forms of birth control during and 6 months after treatment.
You will not qualify if you...
- Received anti-thymocyte globulin within 14 days, or donor lymphocyte infusion or campath within 28 days before enrollment.
- Have other uncontrolled infections, except HIV/AIDS. Bacterial infections must be improving with therapy. Fungal infections must be improving with systemic treatment.
- Active steroid-refractory graft versus host disease.
- Receiving immunosuppressive therapy other than tacrolimus, sirolimus, or steroids.
- Active and uncontrolled relapse of malignancy. Controlled malignancy on maintenance therapy is allowed.
AI-Screening
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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
CONTACT
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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