Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
NCT ID: NCT03266627
Last Updated: 2025-08-08
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
PHASE2
20 participants
INTERVENTIONAL
2018-11-01
2027-12-31
Brief Summary
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Funding Source: FDA OOPD
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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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patients with adenoviral infection
patients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions.
cytotoxic t-lymphocytes
adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.
Interventions
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cytotoxic t-lymphocytes
adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of CTL infusion Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s) Any medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection 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.
Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.
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
University of Colorado, Denver
OTHER
Indiana University
OTHER
Washington University School of Medicine
OTHER
University of California, Los Angeles
OTHER
New York Medical College
OTHER
Responsible Party
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Mitchell Cairo
Principal Investigator
Principal Investigators
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Mitchell Cairo, MD
Role: PRINCIPAL_INVESTIGATOR
New York Medical College
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
University of Colorado Denver
Aurora, Colorado, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
Nationwide Children's Hosptial
Columbus, Ohio, United States
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin/Children's Hospital 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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FD006363
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NYMC 579
Identifier Type: -
Identifier Source: org_study_id
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