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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197596
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : October 25, 2022
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Medical College of Wisconsin
Nationwide Children's Hospital
Johns Hopkins University
University of California, San Francisco
Information provided by (Responsible Party):
New York Medical College

Study Description
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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).

Condition or disease Intervention/treatment Phase
Viral Infection Primary Immune Deficiency Disorder Biological: BK CTL Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
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Arm Intervention/treatment
Experimental: BK CTL
Eligible patients with refractory BK infection will receive up to 5 infusions of BK CTLs that are donor derived.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 12 weeks ]
    Patients will be monitored for adverse events following each CTL infusion


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 30.99 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197596


Contacts
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Contact: Mitchell S Cairo, MD 9145942150 mitchell_cairo@nymc.edu
Contact: Lauren Harrison 16172857844 lauren_harrison@nymc.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Julia Chu, MD       Julia.Chu2@ucsf.edu   
United States, Colorado
Children's Hospital of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Michael Verneris, MD    720-777-1234    Michael.Verneris@childrenscolorado.org   
Contact: Amanda Kinderman, MPH    303-724-3652    amanda.kinderman@ucdenver.edu   
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kenneth Cooke, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Shalini Shenoy, MD       shalinishenoy@wustl.edu   
United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell S Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Contact: Lauren Harrison, RN    6172857844    lauren_harrison@nymc.edu   
Principal Investigator: Mitchell S. Cairo, MD         
United States, Ohio
Nationwide Children's Hosptial Recruiting
Columbus, Ohio, United States, 43205
Contact: Dean Lee, MD, PhD    614-722-3550    Dean.Lee@nationwidechildrens.org   
United States, Pennsylvania
Children's Hospital of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nancy Bunin, MD    215-590-2255    buninn@email.chop.edu   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Julie A Talano, MD    414-955-4185    jtalano@mcw.edu   
Principal Investigator: Julie A Talano, MD         
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Mitchell S Cairo, MD New York Medical College
More Information
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Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT04197596    
Other Study ID Numbers: NYMC 590
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Virus Diseases
Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
 Disease Attributes
Pathologic Processes
Immune System Diseases
Genetic Diseases, Inborn