RECRUITING

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

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Conditions

Viral InfectionPrimary Immune Deficiency Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2020-07-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04197596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Medical intolerance to anti-viral therapies including:
  3. * 2 renal toxicity with cidofovir or other \> grade 2 toxicities secondary to cidofovir And/or
  4. * known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
  5. 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
  6. 1. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK CTL infusion
  7. 2. Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
  8. 3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
  9. 4. Thymoglobulin (ATG) or Alemtuzumab within 30 days
  10. 5. Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30%
  11. 6. Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection.
  12. 7. Any medical condition which could compromise participation in the study according to the investigator's assessment
  13. 8. Known HIV infection
  14. 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.
  15. 10. Known hypersensitivity to iron dextran
  16. 11. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
  17. 12. Known human anti-mouse antibodies
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mitchell S Cairo, MD
CONTACT
9145942150
mitchell_cairo@nymc.edu
Lauren Harrison
CONTACT
16172857844
lauren_harrison@nymc.edu

Principal Investigator

Mitchell S Cairo, MD
PRINCIPAL_INVESTIGATOR
New York Medical College

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94158
United States
Children's Hospital of Colorado
Aurora, Colorado, 80045
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Washington University
Saint Louis, Missouri, 63130
United States
New York Medical College
Valhalla, New York, 10595
United States
Nationwide Children's Hosptial
Columbus, Ohio, 43205
United States
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: New York Medical College

  • Mitchell S Cairo, MD, PRINCIPAL_INVESTIGATOR, New York Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2020-07-01
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Viral Infection
  • Primary Immune Deficiency Disorder