NCT02532452 Third Party Viral Specific T-cells (VSTs)
| NCT ID | NCT02532452 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Viral Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2015-09-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 750 participants in total. It began in 2015-09-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
Eligibility Criteria
Inclusion Criteria: * Immunocompromised patient with evidence of viral infection or reactivation * Age \>1 day * Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion * Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent * Must be able to receive CTL infusion in Cincinnati * Informed consent obtained by PI or sub-investigator either in person or by phone Exclusion Criteria: * Active acute GVHD grades II-IV * Uncontrolled bacterial or fungal infection * Uncontrolled relapse of malignancy requiring treatment with chemotherapy * Infusion of ATG or alemtuzumab within 2 weeks of VST infusion * Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days
Contact & Investigator
Michael Grimley, MD, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT02532452 clinical trial?
This trial is open to participants of all sexes, aged 2 Days or older, studying Viral Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02532452 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02532452 currently recruiting?
Yes, NCT02532452 is actively recruiting participants. Contact the research team at Jamie.Wilhelm@cchmc.org for enrollment information.
Where is the NCT02532452 trial being conducted?
This trial is being conducted at Akron, United States, Cincinnati, United States, Cincinnati, United States, Columbus, United States.
Who is sponsoring the NCT02532452 clinical trial?
NCT02532452 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Michael Grimley, MD, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 750 participants.