Recruiting

NCT Number: NCT02048332

Donor-Derived Viral Specific T-cells (VSTs)

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.

Recruiting

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Key information

Conditions

Allogeneic Stem Cell Transplant Adenoviridae Infections DNA Virus Infections Epstein-Barr Virus Infections Herpesviridae Infections Infections Tumor Virus Infections Viral Infection Viral Reactivation Virus Diseases

Age range

4 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Akron Children's Hospital, Akron, Ohio, United States

About this study

The stem cell matched donor will be asked to provide a blood donation for the VSTs generation. In the laboratory, the investigators will treat this blood sample to select out the cells that will help fight viruses. The cells will be grown with peptides (protein fragments that represent parts of the virus that will encourage the donor immune cells to grow). The cells will be grown in the laboratory so that there is a stock of virus fighting cells for the patient to use in the future. The investigators will freeze the cells and store them in a freezer in the laboratory.

If the patient has signs of virus in their blood after the transplant, they will be given the cells to help fight the infection. If there are signs that the cells are helping fight the infection, more cells may be given. The patient may get the cells up to 5 times, with 21 days between each treatment (this timeframe may be shortened to 14 days for patients with no evidence of viral response). If the patient does not show signs of a virus, the cells will stay in the freezer.

Following VST infusion, (s)he will be monitored with physical exams daily while inpatient and weekly while outpatient as well as blood tests weekly until 30 days after the last infusion of cells. The patient will have 3 teaspoons (15 mL) of blood drawn and urine collected before each cell infusion and then once a week after each infusion for 4 weeks and then once a month if possible for 1 year after the last infusion, all to monitor for the viral response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Viral Specific VST Infusion

Biological

VSTs 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.

Primary outcomes

Successful production of viral specific T-cells

Time frame: Within 30 days post culture initiation

Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Percentage of patients who do not have infusional toxicity

Time frame: Through 30 minutes post infusion

Patients will be monitored for infusional toxicity
Incidence of GVHD associated with VST infusion

Time frame: Through 30 days after infusion

Patients will be monitored for the development of VST associated GVHD

Secondary outcomes

Presence of viral-specific T-cells

Time frame: At 30 days after infusion

Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Viral burden

Time frame: At 30 days after infusion

The viral burden will be assessed using the protocol-defined efficacy assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie Wilhelm, BS

CONTACT

[email protected]

(513) 803-1102

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

Hoxworth Blood Center

Registry information

Official study title

Donor-Derived Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Allogeneic Stem Cell Transplant

Acronym: VSTs

Important dates

Study start: 2014
Primary completion: 2027
Study completion: 2027
First posted: Jan 29, 2014
Registry last updated: Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed