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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
viral specific cytotoxic t-lymphocytes
DrugCMV 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Refractory CMVExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Patients will be monitored for adverse events following the administration of CMV CTLs
Time frame
Patients will be followed for 12 weeks after each infusion2
Incidence of Response to Treatment
Patients will be followed for improvement in viral infection by monitoring CMV PCR weekly for response to treatment with CTLs
Time frame
Patients will be followed 12 weeks after each infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
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