Primary Immune Deficiency Disorder, Viral Infection
Conditions
Brief 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).
Interventions
BIOLOGICALBK CTL
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).
Sponsors
New York Medical College
Children's Hospital of Philadelphia
Medical College of Wisconsin
Nationwide Children's Hospital
Johns Hopkins University
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 79 Years
Healthy volunteers
No
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: * 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 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test Exclusion: 1. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK CTL infusion 2. Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion 3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion 4. Thymoglobulin (ATG) or Alemtuzumab within 30 days 5. Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% 6. Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection. 7. Any medical condition which could compromise participation in the study according to the investigator's assessment 8. Known HIV infection 9. Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment. 10. Known hypersensitivity to iron dextran 11. Patients unwilling or unable to comply with the protocol or unable to give informed consent. 12. Known human anti-mouse antibodies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 12 weeks | Patients will be monitored for adverse events following each CTL infusion |
Countries
United States
Contacts
CONTACTMitchell S Cairo, MD
CONTACTLauren Harrison
PRINCIPAL_INVESTIGATORMitchell S Cairo, MD
New York Medical College
Outcome results
None listed