Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections

Recruiting Phase 1 Phase 2 Interventional Study
Adenovirus Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
Up to 60
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Nationwide Children's Hospital · Other
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About This Trial
This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age 0 days to 60 years with one of the following conditions: 1. Patients who are solid organ transplantation recipients (renal, heart, lung, liver, pancreas, small bowel, multi-visceral) and are \> 28 days post-transplant at the time of screening. 2. Patients with underly…
Contacts

Melinda Triplet

6147226039

Melinda.Triplet@nationwidechildrens.org

CONTACT