Using donor-derived T-cells to treat viral infections after stem cell transplants
Donor-Derived Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Allogeneic Stem Cell Transplant
PHASE1; PHASE2 · Children's Hospital Medical Center, Cincinnati · NCT02048332
This study is testing whether T-cells from stem cell donors can help patients who have infections after their transplants fight off those viruses.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 4 Weeks and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Drugs / interventions | alemtuzumab, chemotherapy, prednisone |
| Locations | 3 sites (Akron, Ohio and 2 other locations) |
| Trial ID | NCT02048332 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of donor-derived viral specific T-cells (VSTs) to combat viral infections that may arise following allogeneic stem cell transplants. Participants who have undergone or are scheduled for such transplants will receive VST infusions if they show signs of viral infections. The T-cells are generated from the donor's blood and are specifically designed to target and eliminate virus-infected cells. Patients will be monitored closely for their response to the treatment, with the possibility of receiving multiple infusions if necessary.
Who should consider this trial
Good fit: Ideal candidates are adults who are at least 21 days post-allogeneic stem cell transplant and have achieved engraftment.
Not a fit: Patients with active acute graft-versus-host disease or uncontrolled infections may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of viral infections and associated complications in patients post-transplant.
How similar studies have performed: Other studies have shown promise in using T-cell therapies for viral infections post-transplant, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Recipient 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 * Recipient must have achieved engraftment with ANC ≥ 500 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
Where this trial is running
Akron, Ohio and 2 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)
Study contacts
- Principal investigator: Michael Grimley, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Jamie Wilhelm, BS
- 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.
Conditions: Allogeneic Stem Cell Transplant, Viral Infection, Viral Reactivation, Epstein-Barr Virus, Adenovirus, t-cells, donor, transplant