NCT02048332 Donor-Derived Viral Specific T-cells (VSTs)
| NCT ID | NCT02048332 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Allogeneic Stem Cell Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2014-02-05 |
| Primary Completion | 2027-01 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 1,000 participants in total. It began in 2014-02-05 with a primary completion date of 2027-01.
⚠ 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
In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant. The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death. Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find an easier way to treat these infections.
Eligibility 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
Contact & Investigator
Michael Grimley, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT02048332 clinical trial?
This trial is open to participants of all sexes, aged 4 Weeks or older, studying Allogeneic Stem Cell Transplant. 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 NCT02048332 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02048332 currently recruiting?
Yes, NCT02048332 is actively recruiting participants. Contact the research team at Jamie.Wilhelm@cchmc.org for enrollment information.
Where is the NCT02048332 trial being conducted?
This trial is being conducted at Akron, United States, Cincinnati, United States, Cincinnati, United States.
Who is sponsoring the NCT02048332 clinical trial?
NCT02048332 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Michael Grimley, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 1,000 participants.