Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

NCT04230356 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2019-1217
• Study Type: interventional
• Target: 180
• 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 prevent or treat viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT). Stem cell transplant reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. 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.

Conditions

Allogeneic Stell Cell Transplant; Viral Infection

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Failures

  Treatment failure is defined as EBV\>100,000, BKV \>100,000, CMV \>5,000 or Adv \>50,000 at any time post randomization.

  21 - 100 days after transplant

Study Arms (2)

VSTs to Prevent

EXPERIMENTAL

VSTs are given through an IV infusion 21-30 days after transplant to see if the VSTs will help prevent a viral infection.

Biological: Viral Specific T-cells (VSTs) Scheduled

VSTs to Treat

EXPERIMENTAL

VSTs will be given only if a viral infection develops.

Biological: Viral Specific T-cells (VSTs) Treatment

Interventions

Viral Specific T-cells (VSTs) Scheduled BIOLOGICAL

VSTs will be infused into stem cell transplant recipients on schedule.

VSTs to Prevent

Viral Specific T-cells (VSTs) Treatment BIOLOGICAL

VSTs will be infused into stem cell transplant recipients only if viremia is detected.

VSTs to Treat

Eligibility Criteria

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

You may qualify if:

• Recipient must be at least 21 days after stem cell infusion
• Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent
• No critical illness making VST infusion hazardous

You may not qualify if:

• Active acute GVHD grades II-IV.
• Uncontrolled relapse of malignancy.
• Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. The level must be less than or equal to 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for scheduled VST infusion at that point.
• TREATMENT ARM
• Blood adenovirus PCR ≥1,000
• Blood CMV PCR ≥ 500
• Blood EBV PCR ≥ 9,000
• Plasma BKV 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, defined as pneumonitis, retinitis, colitis, hepatitis
• 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, defined as hemorrhagic cystitis or BK nephropathy.
• No active acute GVHD grades II-IV
• No uncontrolled relapse of malignancy
• No infusion of ATG or alemtuzumab within 2 weeks of VST infusion.

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

RECRUITING

MeSH Terms

Conditions

Virus Diseases

Interventions

Appointments and Schedules; Therapeutics

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Stella Davies, MBBS, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celeste Dourson, MS

CONTACT

513-636-7679; Celeste.Dourson@cchmc.org

Jamie Wilhelm, BS

CONTACT

513-803-1102; Jamie.Wilhelm@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: January 27, 2021
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)