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

Recruiting Phase 1 Phase 2 Interventional Study
Viral Infection Primary Immune Deficiency Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 Month – 79
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
New York Medical College · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
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 de…
Contacts

Mitchell S Cairo, MD

9145942150

mitchell_cairo@nymc.edu

CONTACT

Lauren Harrison

16172857844

lauren_harrison@nymc.edu

CONTACT