Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
NCT ID: NCT04197596
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2020-07-01
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BK CTL
Eligible patients with refractory BK infection will receive up to 5 infusions of BK CTLs that are donor derived.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
1 Month
79 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
Medical College of Wisconsin
OTHER
Nationwide Children's Hospital
OTHER
Johns Hopkins University
OTHER
University of California, San Francisco
OTHER
New York Medical College
OTHER
Responsible Party
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Principal Investigators
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Mitchell S Cairo, MD
Role: PRINCIPAL_INVESTIGATOR
New York Medical College
Locations
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University of California San Francisco
San Francisco, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Johns Hopkins
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
New York Medical College
Valhalla, New York, United States
Nationwide Children's Hosptial
Columbus, Ohio, United States
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Kenneth Cooke, MD
Role: primary
Other Identifiers
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NYMC 590
Identifier Type: -
Identifier Source: org_study_id
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