Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age5-25
SponsorChildren's Hospital of Philadelphia

About this trial

This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.

Eligibility criteria

Qualifiers

Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy

Symptoms of cystitis may include: hematuria (microscopic or gross), pain with urination, frequency, bladder spasms.

Patient may be otherwise treated for cystitis as per local institutional standards. Such treatments may include hydration, antiviral medications, or surgical intervention as deemed appropriate by treating physician.

Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.

Disqualifiers

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

Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK Virus CTL infusion or within 3 days of planned infusion.

Thymoglobulin (ATG), campath or T cell immunosuppressive monoclonal antibodies within 30 days

Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30%

Trial design

Treatments tested in this trial

  • BK-virus specific CTLs

Treatment groups

20 Participants
are divided into 1 treatment group