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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04197596
Other study ID # NYMC 590
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2020
Est. completion date June 30, 2025

Study information

Verified date May 2024
Source New York Medical College
Contact Mitchell S Cairo, MD
Phone 9145942150
Email mitchell_cairo@nymc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 79 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
BK 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 five 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).

Locations

Country Name City State
United States Children's Hospital of Colorado Aurora Colorado
United States Johns Hopkins Baltimore Maryland
United States Nationwide Children's Hosptial Columbus Ohio
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Children's Hospital of Pennsylvania Philadelphia Pennsylvania
United States Washington University Saint Louis Missouri
United States University of California San Francisco San Francisco California
United States New York Medical College Valhalla New York

Sponsors (6)

Lead Sponsor Collaborator
New York Medical College Children's Hospital of Philadelphia, Johns Hopkins University, Medical College of Wisconsin, Nationwide Children's Hospital, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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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