Lab-Grown immune cells take on dangerous viruses in vulnerable patients
NCT ID NCT02479698
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests whether specially grown donor immune cells (called cytotoxic T lymphocytes) can safely and effectively control BK and JC virus infections in people with weakened immune systems, such as those with cancer, HIV, or organ transplants. About 100 participants will receive these cells and be monitored for response and side effects. The goal is to reduce the virus and prevent complications, not to cure the underlying condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2015
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients ≥ 2 years. * English and non-English speaking patients are eligible. * Immunocompromised patients including but not limited to those with any type of malignancy, HIV/AIDS, or history of solid organ transplant * Non-immunocompromised patients with PML/JC virus encephalitis * Microscopic or greater hematuria urine or blood PCR positive for BK virus * Biopsy proven BK nephritis and urine or blood PCR positive for BK virus disease and/or polyomavirus. * Definite or probable PML/JC viral encephalitis (see Appendix C) * JC end-organ disease * Receiving \> 6 mg / day of prednisone or equivalent at the time of enrollment. * Patients with BK virus hemorrhagic cystitis, who are receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion. * Patients with JCV encephalitis / PML may be receiving pembrolizumab. * Written informed consent and/or signed assent from patient, parent or guardian. * Patients with cognitive impairments are eligible. * A negative pregnancy test in female patients of childbearing potential. Childbearing potential is defined as pre-menopausal, post-menopausal for \< 1 year, and not having undergone surgical sterilization. * Women of childbearing potential must be willing to use an effective contraceptive measure while on study. * Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI. * Patients with bacterial infections must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. * Patients with fungal infections patients must be receiving definitive systemic anti fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. * Patients may be re-enrolled in the protocol if the BK or JC virus infection recurs, so long as they meet all the other eligibility criteria at the time of re-enrollment. Exclusion Criteria: * Patients receiving \> 6 mg / day of prednisone or equivalent at time of * Patients who have received ATG within 14 days of enrollment * Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment. * Patients who have received alemtuzumab within 28 days of enrollment. * Patients with other uncontrolled infections (including HIV/AIDS). Uncontrolled infection is defined as the presence of hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as uncontrolled infection. * Patients with active acute GVHD grades II-IV.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acquired immunodeficiency syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tiny tweets, big impact? testing digital nudges to boost HIV prevention
- Banked t cells target four viruses at once in children after transplant
- Can a phone app help young adults with HIV stay on track?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can a mouth rinse reveal hidden HPV risks in HIV patients?
- Can a Two-Pronged attack shrink advanced solid tumors?