Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
NCT ID: NCT03266640
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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Refractory CMV
Patients with refractory CMV will be given one dose of CMV specific CTLs. HLA matched donors will get Dose 2.5 × 10(4) CD3/kg recipient weight; HLA mismatched will get 0.5x10(4) CD3/kg recipient weight. Additional doses may be given for a total of 5 doses if patients do not have a response to the first dose with a reduction in viral load to normal limits.
viral specific cytotoxic t-lymphocytes
CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.
Interventions
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viral specific cytotoxic t-lymphocytes
CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.
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 CMV CTL infusion Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of CMV CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CMV CTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal antibodies within 30 days Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory CMV 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 CMV retinitis, meningitis, encephalitis, and/or cerebritis
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
Washington University School of Medicine
OTHER
Indiana University
OTHER
Children's Hospital 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 S 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
Indiana University
Indianapolis, Indiana, 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 580
Identifier Type: -
Identifier Source: org_study_id
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