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

S
Scott Goebel, MD

Primary Investigator

Overview

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

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Viral Infection, Primary Immune Deficiency Disorder
  • Age: Between 1 Month - 30 Years
  • Gender: All

Inclusion Criteria:
        .1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organwith primary immunodeficiencies with eitherg urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistentquantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriateviral therapy AND/ORdical intolerance to anti-viral therapies including:2 renal toxicity with cidofovir or other > grade 2 toxicities secondary todofovir And/orknown resistance to cidofovir 1.2. Consent: Written informed consent given (by patientgal 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 30.99years 1.5 Females of childbearing potential with a negative urine pregnancy testusion:1. Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTLusion2. Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK CTLusion3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTLusion. Thymoglobulin (ATG) or Alemtuzumab within 30 days5. Patient with poor performance status determined by Karnofsky (patients >16 years) orLansky (patients ≤16 years) score ≤30%6. Concomitant enrollment in another experimental clinical trial investigating they BK infection.7. Any medical condition which could compromise participation in the study according tohe investigator's assessment8. Known HIV infection9. Female patient of childbearing age who is pregnant or breast-feeding or not willing touse an effective method of birth control during study treatment.10. Known hypersensitivity to iron dextran11. Patients unwilling or unable to comply with the protocol or unable to give informed.12. Known human anti-mouse antibodies

Updated on 29 Apr 2024. Study ID: NYMC 590
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