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

ConditionsViral InfectionPrimary Immune Deficiency Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-79
SponsorNew York Medical College

About this trial

BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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.

Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTL infusion

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • BK CTL

    Biological/Vaccine

    Patient with refractory BK infection and a HLA Matched Related Donors: BK specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of twenty total infusions (maximum 12.5 x 104 CD3/kg). Patients with refractory BK virus and a HLA Mismatched Related Donors: BK specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: BK CTLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Patients will be monitored for adverse events following each CTL infusion

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York Medical College

Lead sponsor

Children's Hospital of Philadelphia

Collaborator

Medical College of Wisconsin

Collaborator

Nationwide Children's Hospital

Collaborator

Johns Hopkins University

Collaborator

University of California, San Francisco

Collaborator

Source ClinicalTrials.gov
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