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

Description

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.

Conditions

BK Polyomavirus

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Study Overview

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Study Details

Study overview

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.

A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients

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

Condition
BK Polyomavirus
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.
  • * Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).

Ages Eligible for Study

5 Weeks to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital of Philadelphia,

Caitlin Elgarten, MD, MSCE, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

2025-12-30