Using immune cells to treat BK virus infection in transplant patients
A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients
This study is testing whether specially treated immune cells can help transplant patients with BK virus infections feel better and reduce the virus in their bodies.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 5 Weeks to 25 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04293042 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and effectiveness of cytotoxic T lymphocytes (CTLs) specifically targeting the BK virus in patients experiencing viremia and related symptoms after undergoing allogeneic hematopoietic stem cell transplantation, renal transplantation, or chemotherapy. The CTLs are produced using the Miltenyi CliniMACS Prodigy system, which isolates and activates these immune cells from the patient's blood. The trial is open-label and single-arm, focusing on patients with elevated BK virus DNA and symptoms such as cystitis. The goal is to reduce viral load and alleviate symptoms associated with BK virus infection.
Who should consider this trial
Good fit: Ideal candidates are immunocompromised patients aged 0.1 to 25 years with symptoms of cystitis and elevated BK virus DNA following transplantation or chemotherapy.
Not a fit: Patients without symptoms of cystitis or those who do not have elevated BK virus DNA may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for immunocompromised patients suffering from BK virus infections.
How similar studies have performed: While this approach is innovative, similar studies targeting viral infections with CTLs have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Caitlin Elgarten, MD, MSCE — Children's Hospital of Philadelphia
- Study coordinator: Megan Atkinson
- Email: cttsbmtintake@chop.edu
- Phone: 215-590-2820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.