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

Phase 2

Active, not recruiting

• Conditions: Viral Infection; Solid Organ Transplant
• Interventions: Biological: Viral Specific T-cells (VSTs)

• Registration Number: NCT04331275
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-02
• Study Start: 2020-08-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11
• Primary Completion: 2026-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viral Specific T-cells (VSTs)	Viral Specific T-cells (VSTs)	-

Primary Outcome Measures

Name	Time	Method
Successful production of viral specific T-cells	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States