EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection
NCT ID: NCT03266653
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
2020-07-07
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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Refractory EBV
Patients with refractory EBV will get one dose of EBV specific CTLs. If they don't show a response based on EBV PCRs, patients may get up to another 4 doses of EBV-CTLs (5 doses maximum)
cytotoxic t-lymphocytes
EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs.
Interventions
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cytotoxic t-lymphocytes
EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs.
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 EBV infection 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
Indiana University
OTHER
Washington University School of Medicine
OTHER
University of California, Los Angeles
OTHER
University of California, San Francisco
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 Hosptial Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, 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/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 581
Identifier Type: -
Identifier Source: org_study_id
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