Actively Recruiting

Phase 1
Phase 2
Age: 4Weeks +
All Genders
NCT02048332

Donor-Derived Viral Specific T-cells (VSTs)

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-12-16

750

Participants Needed

3

Research Sites

673 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

H

Hoxworth Blood Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant. The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death. Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. 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 an easier way to treat these infections.

CONDITIONS

Official Title

Donor-Derived Viral Specific T-cells (VSTs)

Who Can Participate

Age: 4Weeks +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Recipient must be at least 21 days after stem cell infusion
  • Clinical status must allow tapering of steroids to 0.5mg/kg prednisone or other steroid equivalent
  • Recipient must have achieved engraftment with ANC 26500
Not Eligible

You will not qualify if you...

  • Active acute GVHD grades II-IV
  • Uncontrolled bacterial or fungal infection
  • Uncontrolled relapse of malignancy requiring chemotherapy
  • Infusion of ATG or alemtuzumab within 2 weeks of VST infusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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+1

Trial Site Locations

Total: 3 locations

1

Akron Children's Hospital

Akron, Ohio, United States, 44308

Actively Recruiting

2

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Completed

3

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

J

Jamie Wilhelm, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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