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Cytotoxic T Lymphocytes for Malignancies with BK and/or JC Virus

This study is looking at how well a treatment called allogeneic BK-specific Cytotoxic T-lymphocytes (special immune cells) works in people with cancer (malignancies) who also have BK and/or JC virus infections. These immune cells are grown in a lab from donated blood and are designed to fight viruses. Researchers want to see if these cells can effectively treat the infections and potentially help with the cancer. You might be able to join if you are at least 2 years old, are immunocompromised, have certain types of cancer, HIV/AIDS, or a history of organ transplant. The study will measure how well the treatment works, any side effects, and how long the immune cells stay in your body.

Study design
This is an interventional study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive allogeneic BK-specific Cytotoxic T-lymphocytes intravenously. If you respond well, you might receive up to 7 additional infusions.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up periodically for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02479698

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

Recruiting
PHASE2All AgesInterventionalTreatment
M.D. Anderson Cancer Center
~100 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Allogeneic BK-specific Cytotoxic T-lymphocytesLaboratory Biomarker Analysis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response, defined as response (R) = (best response [R1] or second best response [R2])
Measured over Up to 56 days
+2 more outcomes measured

Conditions

Acquired Immunodeficiency Syndrome
BK Virus Infection
Human Immunodeficiency Virus
JC Virus Infection
Malignant Neoplasm
Merkel Cell Carcinoma
Merkel Cell Polyomavirus Infection
Viral Encephalitis

Explore related trials

Acquired Immunodeficiency SyndromeBK Virus InfectionJC Virus InfectionMalignant NeoplasmMerkel Cell CarcinomaViral EncephalitisBK virusJC virusMerkel cell polyomavirus

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • George Chen, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

George Chen, MD
[email protected]
713-792-3630
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Response, defined as response (R) = (best response [R1] or second best response [R2])Up to 56 days

    The method of Thall et al will be used to monitor the probabilities of response.

  • Incidence of acute graft-versus-host disease (GVHD)Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs)

    The method of Thall et al will be used to monitor the probabilities of grade 3 or 4 GVHD.

  • Incidence of adverse eventsUp to day 100

    Will be continuously monitored.