Infusion of donor-derived T-cells for viral infections in immunocompromised patients
Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
This study is testing whether T-cells from donors can help children with weakened immune systems fight off viral infections like EBV, CMV, and ADV after they have had stem cell transplants.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 2 Days and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | alemtuzumab, chemotherapy, prednisone |
| Locations | 4 sites (Akron, Ohio and 3 other locations) |
| Trial ID | NCT02532452 on ClinicalTrials.gov |
What this trial studies
This study aims to generate viral specific T-cells (VSTs) from unrelated donors to treat immunocompromised patients suffering from viral infections such as Epstein-Barr virus (EBV), cytomegalovirus (CMV), and adenovirus (ADV). Blood will be collected from donors to create these T-cells, which will then be infused into patients based on their HLA type and the specific viral infection they are facing. The goal is to demonstrate the safety and efficacy of this approach in managing viral reactivation and infections in vulnerable populations, particularly children who have undergone stem cell transplants.
Who should consider this trial
Good fit: Ideal candidates include immunocompromised children with evidence of viral infection or reactivation who are at least 21 days post-stem cell transplant.
Not a fit: Patients with active acute graft-versus-host disease, uncontrolled infections, or recent chemotherapy treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for immunocompromised patients suffering from serious viral infections.
How similar studies have performed: Other studies have shown promise in using donor-derived T-cells for treating viral infections in immunocompromised patients, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Akron, Ohio and 3 other locations
- Akron Children's Hospital — Akron, Ohio, United States (Recruiting)
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Completed)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- The Ohio State University Wexner Medical Center - James Cancer Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Michael Grimley, MD, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Jamie Wilhelm
- Email: Jamie.Wilhelm@cchmc.org
- Phone: (513) 803-1102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.