NCT04293042 Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
| NCT ID | NCT04293042 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | BK Polyomavirus |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-10-07 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2019-10-07 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.
Eligibility Criteria
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 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. Donor Eligibility * 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. 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
Contact & Investigator
Caitlin Elgarten, MD, MSCE
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT04293042 clinical trial?
This trial is open to participants of all sexes, aged 5 Weeks or older, up to 25 Years, studying BK Polyomavirus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04293042 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04293042 currently recruiting?
Yes, NCT04293042 is actively recruiting participants. Contact the research team at cttsbmtintake@chop.edu for enrollment information.
Where is the NCT04293042 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT04293042 clinical trial?
NCT04293042 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Caitlin Elgarten, MD, MSCE at Children's Hospital of Philadelphia. The trial plans to enroll 20 participants.