Status:
RECRUITING
Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
BK Polyomavirus
Eligibility:
All Genders
5-25 years
Phase:
EARLY_PHASE1
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...
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 genera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04293042
Start Date
October 7 2019
End Date
December 30 2028
Last Update
April 29 2025
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104