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Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant

Primary Purpose

Solid Organ Transplant, Viral Infection

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Viral Specific T-cells (VSTs)

About this trial

This is an interventional treatment trial for Solid Organ Transplant

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Blood adenovirus PCR ≥1,000
Blood CMV PCR ≥ 500
Blood EBV PCR ≥ 1,000
Plasma BKV PCR >1,000
Plasma JC Virus PCR > 1,000
Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.
Evidence of invasive CMV infection, e.g. pneumonitis, retinitis, colitis.
Evidence of 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.
Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, BK viruria or BK nephropathy
Evidence of PML or other CNS infection due to JC virus
Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent, or a clinically acceptable steroid dose at the discretion of the PI
Age > 1 day
Must be able to receive VST infusion in Cincinnati

Exclusion Criteria:

Uncontrolled bacterial or fungal infection

Sites / Locations

Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Viral Specific T-cells (VSTs)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Presence of viral-specific T-cells

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

Full Information

NCT ID

NCT04331275

First Posted

March 31, 2020

Last Updated

February 22, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Hoxworth Blood Center

1. Study Identification

Unique Protocol Identification Number

NCT04331275

Brief Title

Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant

Official Title

Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Solid Organ Transplant

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 18, 2020 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Hoxworth Blood Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to treat viral infections that may happen after solid organ transplant (SOT). VSTs are cells specially designed to fight viral infections that may happen after a solid organ transplant. These cells are created from a blood sample collected from the study participant. Solid organ transplant and the use of immunosuppressive medications reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Reduction of immunosuppression may put the organ at risk of rejection. 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 a better way to treat these infections and minimize complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Organ Transplant, Viral Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Viral Specific T-cells (VSTs)

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Viral Specific T-cells (VSTs)

Intervention Description

VSTs will be infused into solid organ transplant recipients who have evidence of viral infection.

Primary Outcome Measure Information:

Title

Successful production of viral specific T-cells

Description

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 initiation

Secondary Outcome Measure Information:

Title

Presence of viral-specific T-cells

Description

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

Time Frame

At 30 days after infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Blood adenovirus PCR ≥1,000 Blood CMV PCR ≥ 500 Blood EBV PCR ≥ 1,000 Plasma BKV PCR >1,000 Plasma JC Virus PCR > 1,000 Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx. Evidence of invasive CMV infection, e.g. pneumonitis, retinitis, colitis. Evidence of 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. Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, BK viruria or BK nephropathy Evidence of PML or other CNS infection due to JC virus Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent, or a clinically acceptable steroid dose at the discretion of the PI Age > 1 day Must be able to receive VST infusion in Cincinnati Exclusion Criteria: Uncontrolled bacterial or fungal infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shawn Thomas, BSN, RN

Phone

513-226-5603

Shawn.Thomas@cchmc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jamie Wilhelm, BS

Phone

513-803-1102

Jamie.Wilhelm@cchmc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stella Davies, MBBS, PhD, MRCP

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shawn Thomas, BSN, RN

Phone

513-226-5603

Shawn.Thomas@cchmc.org

First Name & Middle Initial & Last Name & Degree

Stella Davies, MBBS, PhD, MRCP

12. IPD Sharing Statement

Learn more about this trial

Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant

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