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โ† Trials
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Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

RecruitingPhase 1, Phase 2Ages 1 Month - 79 YearsAllNew York Medical College
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In plain words

What the trial is, and whether it could suit you

BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค16 years) score โ‰ค30% 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
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What it tests

  • BK CTL
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Where

7 sites
University of California San Francisco
San Francisco, United States
Johns Hopkins
Baltimore, United States
Washington University
St Louis, United States
New York Medical College
Vallhala, United States
Nationwide Children's Hosptial
Columbus, United States
Children's Hospital of Pennsylvania
Philadelphia, United States
Medical College of Wisconsin
Milwaukee, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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