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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Organ Transplant; Viral Infection
• Intervention / Treatment: Biological: Viral Specific T-cells (VSTs)

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jamie Wilhelm, BS; Phone Number: 513-803-1102; Email: Jamie.Wilhelm@cchmc.org
• Study Contact Backup: Name: Shawn Thomas, BSN, RN; Phone Number: 513-226-5603; Email: Shawn.Thomas@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viral Specific T-cells (VSTs)	Biological: Viral Specific T-cells (VSTs); VSTs will be infused into solid organ transplant recipients who have evidence of viral infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of viral-specific T-cells	Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay	At 30 days after infusion

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Hoxworth Blood Center
• Investigators: Principal Investigator: Stella Davies, MBBS, PhD, MRCP, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: 2020-0042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No