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

Recruiting now · Early Phase 1

Conditions studied: BK Polyomavirus

In brief

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.

Key facts

Study ID

NCT04293042

Run by

Children's Hospital of Philadelphia

People needed

20

Starts

2019-10-07

Expected to finish

2029-01-30

Last updated by the study team

2026-06-05

Who can join

Age: 0 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient exclusion criteria:
• 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

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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