RecruitingPhase 1/2

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

United States40 participantsStarted 2020-07-01

Plain-language summary

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).

Who can participate

Age range1 Month – 79 Years

SexALL

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Inclusion criteria

✓.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 criteria

✕. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK CTL infusion
✕. Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
✕. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
✕. Thymoglobulin (ATG) or Alemtuzumab 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 infection.
✕. Any medical condition which could compromise participation in the study according to the investigator's assessment
✕. Known HIV infection

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: 12 weeks

Trial details

NCT IDNCT04197596

SponsorNew York Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Mitchell S Cairo, MD

9145942150 mitchell_cairo@nymc.edu

View on ClinicalTrials.gov More Viral Infection trials