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

NCT04331275 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2020-0042
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Organ Transplant; Viral Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Presence of viral-specific T-cells

  At 30 days after infusion

Study Arms (1)

Viral Specific T-cells (VSTs)

EXPERIMENTAL

Biological: Viral Specific T-cells (VSTs)

Interventions

Viral Specific T-cells (VSTs) BIOLOGICAL

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

Viral Specific T-cells (VSTs)

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled bacterial or fungal infection

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Hoxworth Blood Center: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Stella Davies, MBBS, PhD, MRCP

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

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: March 31, 2020
• First Posted: April 2, 2020
• Study Start: August 18, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)