Pilot Study NYMC 590

NYMC 590

A Pilot Study in the Treatment of Refractory BK Infections with Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients.

https://clinicaltrials.gov/ct2/show/NCT04197596?term=BK+CTLs&draw=2&rank=1

Eligibility

1. Patient Eligibility

1.1-Patients with refractory BK infection post allogeneic HSCT or with primary immunodeficiencies or post solid organ transplantation (SOT) 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 30.99 years

1.5 Females of childbearing potential with a negative urine pregnancy test at study entry only.