BK Polyomavirus
Conditions
Brief 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.
Detailed description
This open-label, single-arm clinical trial will assess the safety and efficacy of BK virus-specific CTLs isolated from whole blood or leukapheresis products. The BK virus -specific CTLs will be generated automatically by the CliniMACS® Prodigy using the CliniMACS Cytokine Capture System (IFNgamma) after incubation with MACS GMP PepTivator® Peptide Pools of BKV VP1 and BKV LT.
Interventions
BIOLOGICALBK-virus specific CTLs
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).
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This open-label, single-arm clinical trial
Eligibility
Sex/Gender
ALL
Age
5 Weeks to 25 Years
Healthy volunteers
No
Inclusion criteria
Patient Eligibility * Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy 1. Symptoms of cystitis may include: hematuria (microscopic or gross), pain with urination, frequency, bladder spasms. 2. 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). 1. Original allogeneic donor if available, IgG positive for BKV or confirmatory testing to respond to BKV MACS Peptivator®. 2. 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 criteria
Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Grade III-IV acute GVHD | Up to 8 weeks after last BK-CTL infusion | Number of participants with Grade III-IV acute GVHD as assessed by CTCAE v4.0 |
| Number of patients with undetectable BK viral load | 12 weeks after first BK-CTL infusion | Number of patients with undetectable BK viral load as measured by qPCR |
Countries
United States
Contacts
CONTACTMegan Atkinson
CONTACTPatricia Hankins, BSN, RN, CCRC
PRINCIPAL_INVESTIGATORCaitlin Elgarten, MD, MSCE
Children's Hospital of Philadelphia
Outcome results
None listed