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BK CTLs for Refractory BK Infections

This study is testing a treatment called BK CTLs (BK specific cytotoxic T-cells) for people with severe BK virus infections that haven't responded to other treatments. These infections can occur after a stem cell transplant, organ transplant, or in individuals with primary immune deficiencies (problems with the immune system). The BK CTLs are given through an IV (intravenous infusion) and may be given multiple times. Researchers want to see if this treatment is safe and if it can reduce the amount of BK virus in your body. The study plans to enroll 40 participants, including children, adolescents, and young adults, aged 1 month to 79 years. The current status of the study is unclear.

Study design
This is an interventional study with an unspecified phase, planning to enroll 40 participants.
What's involved
You would receive BK CTLs intravenously, potentially multiple times, for a maximum of twenty infusions.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability to the treatment will be measured for 12 weeks.

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

NCT04197596

Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

Recruiting
PHASE1Ages 1–79InterventionalTreatment
New York Medical College
~40 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:BK CTL

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured over 12 weeks

Conditions

Viral Infection
Primary Immune Deficiency Disorder

Explore related trials

BK Virus InfectionInborn Error of Immunity

Where it's being run

7 sites across 7 states
California1
Maryland1
Missouri1
New York1
Ohio1
Pennsylvania1
Wisconsin1

Study leadership

  • Mitchell S Cairo, MD · PRINCIPAL_INVESTIGATOR · New York Medical College

Who to contact

Mitchell S Cairo, MD
[email protected]
9145942150
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR
Medical intolerance to anti-viral therapies including:
2 renal toxicity with cidofovir or other \> grade 2 toxicities secondary to cidofovir And/or
known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]12 weeks

    Patients will be monitored for adverse events following each CTL infusion