Using donor-derived T-cells to treat BK infections in patients with weakened immune systems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of BK-specific cytotoxic T-cells (CTLs) in reducing viral load in children, adolescents, and young adults suffering from refractory BK infections following allogeneic hematopoietic stem cell transplantation or those with primary immunodeficiencies. The CTLs are manufactured using the Miltenyi CliniMACS Prodigy Cytokine Capture System. Participants will be monitored for changes in viral load after receiving the CTL treatment, which aims to provide a targeted approach to managing persistent BK infections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

.1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either

* Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR
* Medical intolerance to anti-viral therapies including:

  * 2 renal toxicity with cidofovir or other \> grade 2 toxicities secondary to cidofovir And/or
* known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.

1.3 Performance Status \> 30% (Lansky \< 16 yrs and Karnofsky \> 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test

Exclusion:

1. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK CTL infusion
2. Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
4. Thymoglobulin (ATG) or Alemtuzumab within 30 days
5. Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30%
6. Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection.
7. Any medical condition which could compromise participation in the study according to the investigator's assessment
8. Known HIV infection
9. 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.
10. Known hypersensitivity to iron dextran
11. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
12. Known human anti-mouse antibodies

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting
• Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• New York Medical College
  Vallhala, New York, United States Recruiting
• Nationwide Children's Hosptial
  Columbus, Ohio, United States Recruiting
• Children's Hospital of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Mitchell S Cairo, MD — New York Medical College
• Study coordinator: Mitchell S Cairo, MD
• Email: mitchell_cairo@nymc.edu
• Phone: 9145942150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.