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

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

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: Hoxworth Blood Center

Source 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.

Overall Status Not yet recruiting
Start Date May 2020
Completion Date May 2025
Primary Completion Date May 2024
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Successful production of viral specific T-cells Within 30 days post culture initiation
Secondary Outcome
Measure Time Frame
Presence of viral-specific T-cells At 30 days after infusion
Enrollment 100
Condition
Intervention

Intervention type: Biological

Intervention name: Viral Specific T-cells (VSTs)

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

Arm group label: Viral Specific T-cells (VSTs)

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Adam Nelson, MBBS Principal Investigator Children's Hospital Medical Center, Cincinnati
Overall Contact

Last name: Adam Nelson, MBBS

Phone: 513-803-3218

Email: [email protected]

Location
facility contact investigator
Cincinnati Children's Hospital Medical Center Adam Nelson, MBBS 513-803-3218 [email protected] Adam Nelson, MBBS Principal Investigator
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Viral Specific T-cells (VSTs)

Arm group type: Experimental

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov