NCT02532452

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Sep 2015

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Sep 2015Dec 2027

First Submitted

Initial submission to the registry

August 21, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

September 2, 2015

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

11.3 years

First QC Date

August 21, 2015

Last Update Submit

December 10, 2025

Conditions

Viral InfectionViral ReactivationInfection in an Immunocompromised Host

Keywords

Epstein-Barr Virus (EBV)Adenovirus (ADV)Cytomegalovirus (CMV)T-CellsDonorBK virus (BKV)

Outcome Measures

Primary Outcomes (3)

  • 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.

    Within 30 days post culture initiation

  • Percentage of patients who do not have infusional toxicity

    Patients will be monitored for infusional toxicity

    Through 30 minutes post infusion

  • Incidence of GVHD associated with VST infusion

    Patients will be monitored for the development of VST associated GVHD

    Through 30 days after infusion

Secondary Outcomes (2)

  • Presence of viral-specific T-cells

    At 30 days after infusion

  • Viral burden

    At 30 days after infusion

Study Arms (1)

Viral Specific VST Infusion

EXPERIMENTAL

3rd party VST infusion

Biological: Viral Specific VST Infusion

Interventions

Viral Specific VST InfusionBIOLOGICAL

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

Viral Specific VST Infusion

Eligibility Criteria

Age2 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

COMPLETED

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (4)

  • Rubinstein JD, Pham G, Sridharan A, Khoury R, Wang YM, Hudda Z, Wilhelm J, Lichtenstein DA, Heyenbruch D, Cancelas JA, Davies SM, Lutzko C, Grimley MS. Outcomes with third-party virus-specific T cells after the use of single-antigen cell lines to predict HLA restriction. Blood Adv. 2025 Dec 23;9(24):6305-6313. doi: 10.1182/bloodadvances.2025017097.

    PMID: 40991376DERIVED

  • Galletta TJ, Lane A, Lutzko C, Leemhuis T, Cancelas JA, Khoury R, Wang YM, Hanley PJ, Keller MD, Bollard CM, Davies SM, Grimley MS, Rubinstein JD. Third-Party and Patient-Specific Donor-Derived Virus-Specific T Cells Demonstrate Similar Efficacy and Safety for Management of Viral Infections after Hematopoietic Stem Cell Transplantation in Children and Young Adults. Transplant Cell Ther. 2023 May;29(5):305-310. doi: 10.1016/j.jtct.2023.01.027. Epub 2023 Feb 3.

    PMID: 36736781DERIVED

  • Rubinstein JD, Zhu X, Leemhuis T, Pham G, Ray L, Emberesh S, Jodele S, Thomas S, Cancelas JA, Bollard CM, Hanley PJ, Keller MD, Grimley O, Clark D, Clark T, Lindestam Arlehamn CS, Sette A, Davies SM, Nelson AS, Grimley MS, Lutzko C. Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted. Blood Adv. 2021 Sep 14;5(17):3309-3321. doi: 10.1182/bloodadvances.2021004456.

    PMID: 34473237DERIVED

  • Nelson AS, Heyenbruch D, Rubinstein JD, Sabulski A, Jodele S, Thomas S, Lutzko C, Zhu X, Leemhuis T, Cancelas JA, Keller M, Bollard CM, Hanley PJ, Davies SM, Grimley MS. Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients. Blood Adv. 2020 Nov 24;4(22):5745-5754. doi: 10.1182/bloodadvances.2020003073.

    PMID: 33216887DERIVED

MeSH Terms

Conditions

Virus DiseasesEpstein-Barr Virus InfectionsAdenoviridae Infections

Condition Hierarchy (Ancestors)

InfectionsHerpesviridae InfectionsDNA Virus InfectionsTumor Virus Infections

Study Officials

  • Michael Grimley, MD, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Wilhelm

CONTACT

(513) 803-1102Jamie.Wilhelm@cchmc.org

Michael Grimley, MD

CONTACT

Michael.Grimley@cchmc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 25, 2015

Study Start

September 2, 2015

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

US(4)