Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant

NCT03883906 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2019-0229
• Study Type: interventional
• Target: 30
• 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 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 your 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 we are trying to find a way to prevent these infections.

Conditions

Allogeneic Stem Cell Transplant; Viral Infection

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Presence of a Toxicity

  Participants will be assessed for the presence of a toxicity.

  30 days

• Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)

  Participants will be assessed for the presence of aGVHD.

  30 days

Secondary Outcomes (1)

• Number of Participants With Presence of a Viral Infection

  30 days

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 stem cell transplant recipients

Viral Specific T-cells (VSTs)

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 steroids to \< 0.5mg/kg prednisone or other steroid equivalent

You may not qualify if:

• Patients who have developed viral infection or reactivation will be ineligible for prophylactic infusions of VSTs
• Active acute GVHD grades II-IV
• Uncontrolled relapse of malignancy
• Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab levels will be collected in the second week following stem cell infusion. 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 prophylactic VST infusion at that point if there is still no evidence of viral infection at that time.

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

Results Point of Contact

• Title: Michael Grimley, MD
• Organization: Cincinnati Children's Hospital Medical Center

Michael.Grimley@cchmc.org

513-803-3218

Study Officials

• Michael Grimley, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: March 16, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 1, 2021
• Last Updated: December 13, 2022
• Results First Posted: December 13, 2022

Record last verified: 2022-11

Locations

US (1)