Third Party Viral Specific T-cells (VSTs)

January 23, 2024 updated by: Children's Hospital Medical Center, Cincinnati

Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients

The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Viral reactivation and infection is a major cause of morbidity in immunocompromised patients (including HSCT recipients). In this study we will draw blood from unrelated (third party) donors and use the blood to generate viral specific T-cells (VSTs) with specificity for Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), and JC Virus. The VSTs will be infused into immunocompromised children with specific viral infections (EBV, CMV, ADV, BKV , or JC virus). Cells will be selected for infusion based on the recipient's HLA type and the viral specificity of the cells.

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Akron Children's Hospital
        • Contact:
        • Principal Investigator:
          • Megan Sampson, MD
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Grimley, MD
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Principal Investigator:
          • Bryan Hambley, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center - James Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Polina Shindiapina, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Viral Specific VST Infusion
3rd party VST infusion
Biological: Viral Specific VST Infusion

VSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following:

  • 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 by PCR or culture 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 30 days post culture initiation
Percentage of patients who do not have infusional toxicity
Time Frame: Through 30 minutes post infusion
Patients will be monitored for infusional toxicity
Through 30 minutes post infusion
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
Through 30 days after infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 30 days after infusion
Viral burden
Time Frame: At 30 days after infusion
The viral burden will be assessed using the protocol-defined efficacy assessment.
At 30 days after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Michael Grimley, MD, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2015

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimated)

August 25, 2015

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-4184

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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