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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Children's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGIncidence 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 infusion
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 infusion
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Indiana University
Indianapolis, Indiana, United States
Johns Hopkins
Baltimore, Maryland, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGNew York Medical College
Valhalla, New York, United States
RECRUITINGNationwide Children's Hosptial
Columbus, Ohio, United States
RECRUITINGChildren's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGMedical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITING