Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients (BK-CTLs)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    20
  • sponsor
    Children's Hospital of Philadelphia
Updated on 28 February 2022

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.

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.

Details
Condition BK Polyomavirus
Treatment BK-virus specific CTLs
Clinical Study IdentifierNCT04293042
SponsorChildren's Hospital of Philadelphia
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

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
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 Criteria

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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