T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation

Launched by CHILDREN'S NATIONAL RESEARCH INSTITUTE · Jun 6, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using special immune cells called T-lymphocytes to help prevent or treat viral infections in patients who have received a hematopoietic stem cell transplant (HSCT). After a transplant, patients can be at risk for infections from various viruses, such as CMV, EBV, and adenovirus. The trial aims to see if these specially created T-cells, which can target multiple viruses, are safe to use for patients who either need protection from these viruses or are currently infected and haven’t responded to standard antiviral treatments.

To participate in the trial, patients must have recently undergone an HSCT and meet certain health criteria, such as having stable organ function and a specific level of health status. The study has two groups: one for patients receiving the treatment to prevent infections and another for those with ongoing infections. Participants can expect to receive infusions of the T-cells, and the study will monitor them closely for any side effects. This trial is currently active but not recruiting new participants, and it is important for patients to discuss their eligibility and any questions with their healthcare providers.

Gender

ALL

Eligibility criteria

• Recipient Inclusion Criteria at the Time of Initial VST Infusion and Subsequent Infusions:
• 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells no earlier than 5 days prior to the date of VST infusion. VSTs administered as:
• • 1. Prophylaxis for patients at risk of EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3.
• • 2. Treatment of reactivation or active infection(s) with EBV, CMV, adenovirus, HHV6, BKV, JCV, and/or HPIV3 that has failed to resolve with at least 14 days of standard antiviral therapy (if available and tolerated). Patients with multiple infections due to the targeted viruses are also eligible.
• • 2. Clinical status at infusion allows for tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent. 3) Karnofsky/Lansky score of ≥ 50.
• • 4) Bilirubin ≤ 2x, AST ≤5x, Serum creatinine ≤2x upper limit of normal, Hgb ≥8.0 g/dL (level can be achieved with transfusion).
• • 5) Pulse oximetry of \> 90% on room air. 6) Available multivirus-specific cytotoxic T lymphocytes 7) Negative pregnancy test (if female of childbearing potential). 8) Patient or parent/guardian capable of providing informed consent.
• • Recipient Exclusion Criteria at the Time of Initial VST Infusion and Subsequent Infusions
• • 1. Patients with other uncontrolled infections.
• • 2. Patients who received ATG, Campath, Basiliximab or other T cell immunosuppressive monoclonal antibodies within 28 days prior to VST infusion.
• • 3. Received donor lymphocyte infusion or other cellular therapies (with the exception of allogeneic cells related to transplantation) within 28 days prior to VST infusion.
• • 4. Evidence of acute GVHD grades II-IV.
• • 5. Active and uncontrolled relapse of malignancy.
• • 6. Patients with Grade ≥ 3 hyperbilirubinemia.
• • 7. Patients who have received investigational (IND) product within 28 days prior VST infusion.