Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-79
SponsorNew York Medical College
About this trial
CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.
Funding Source: FDA OOPD
Eligibility criteria
Qualifiers
Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of appropriate anti-viral therapy AND/OR
ANC < 500/mm2 secondary to ganciclovir
2 renal toxicity with foscarnet And/or
known resistance to ganciclovir and/or foscarnet
Disqualifiers
None
Trial design
Treatments tested in this trial
- viral specific cytotoxic t-lymphocytes
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
9California
Children's Hospital Los Angeles90027, Los Angeles United States
University of California San Francisco94158, San Francisco United States
Indiana
Indiana University46202, Indianapolis United States
Maryland
Johns Hopkins21287, Baltimore United States
Sponsors and collaborators
New York Medical College
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Medical College of Wisconsin
Collaborator
Nationwide Children's Hospital
Collaborator
Johns Hopkins University
Collaborator
University of California, San Francisco
Collaborator
Washington University School of Medicine
Collaborator
Indiana University
Collaborator
Children's Hospital Los Angeles
Collaborator
Source ClinicalTrials.gov