Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients
Children's Hospital of Philadelphia
20 participants
Oct 7, 2019
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria16
- Patient Eligibility
- 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.
- Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs)
- Age: 0.1 to 25 years
- Females of childbearing potential with a negative urine pregnancy test.
- Donor Eligibility
- Related donor available with a T-cell response to the BK-virus MACS® PepTivator® antigen(s).
- Original allogeneic donor if available, IgG positive for BKV or confirmatory testing to respond to BKV MACS Peptivator®.
- Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor > 1 HLA A, B, DR match to recipient) with a T-cell response to the BK MACS® PepTivator.
- AND
- Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).
- AND
- Obtained informed consents by donor or donor legally authorized representative prior to donor collection.
Exclusion Criteria12
- A patient meeting any of the following criteria is not eligible for the present study:
- 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%
- Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK virus infection.
- Any medical condition which could compromise participation in the study according to the investigator's assessment
- Known HIV infection
- Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
- Known hypersensitivity to iron dextran
- Patients unwilling or unable to comply with the protocol or unable to give informed consent.
- Known human anti-mouse antibodies
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Interventions
HLA Matched Related Donors: BK-virus 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 five total infusions (maximum 12.5 x 104 CD3/kg). HLA Mismatched Related Donors: BK-virus 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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04293042