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New treatment option for BK Polyomavirus
Official title Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
ClinicalTrials.gov ID: NCT04293042
What this study is testing
What is BK-virus specific CTLs?
BK-virus specific CTLs is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bk polyomavirus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 25
You may be able to join 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...
- Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
You likely can't join 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.
See the full eligibility 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)
- 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 weeks to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.