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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| Medical College of Wisconsin | OTHER |
| Nationwide Children's Hospital | OTHER |
| Johns Hopkins University |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BK CTL | Experimental | Eligible patients with refractory BK infection will receive up to 20 infusions of BK CTLs that are donor derived. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BK CTL | Biological | Patient with refractory BK infection and a HLA Matched Related Donors: BK specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of twenty total infusions (maximum 12.5 x 104 CD3/kg). Patients with refractory BK virus and a HLA Mismatched Related Donors: BK specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Patients will be monitored for adverse events following each CTL infusion | 12 weeks |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitchell S Cairo, MD | Contact | 9145942150 | mitchell_cairo@nymc.edu | |
| Lauren Harrison | Contact | 16172857844 | lauren_harrison@nymc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell S Cairo, MD | New York Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94158 | United States |
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| OTHER |
| University of California, San Francisco | OTHER |
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| Johns Hopkins | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63130 | United States |
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| New York Medical College | Recruiting | Vallhala | New York | 10595 | United States |
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| Nationwide Children's Hosptial | Recruiting | Columbus | Ohio | 43205 | United States |
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| Children's Hospital of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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