Donor-Derived Viral Specific T-cells (VSTs)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4+
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Viral specific VST Infusion
Biological/VaccineVSTs will be infused into stem cell transplant recipients who have evidence of viral infection or reactivation defined as any of the below: * Blood adenovirus PCR ≥ 1,000 * Blood CMV PCR ≥ 500 * Blood EBV PCR ≥ 9,000 * Plasma BKV PCR \>1,000 * Plasma JC Virus PCR \>1,000 * Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity in one or more sites. * Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis * Evidence of invasive EBV disease/infection, EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation, or EBV-associated malignancies. * Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy. * Evidence of PML or other CNS infection due to JC virus.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Viral Specific VST InfusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Successful production of viral specific T-cells
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Time frame
Within 30 days post culture initiation2
Percentage of patients who do not have infusional toxicity
Patients will be monitored for infusional toxicity
Time frame
Through 30 minutes post infusion3
Incidence of GVHD associated with VST infusion
Patients will be monitored for the development of VST associated GVHD
Time frame
Through 30 days after infusionSecondary outcomes
1
Presence of viral-specific T-cells
Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Time frame
At 30 days after infusion2
Viral burden
The viral burden will be assessed using the protocol-defined efficacy assessment
Time frame
At 30 days after infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Hoxworth Blood Center
Collaborator
Source ClinicalTrials.gov