T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation (NATS)
Viral Infections, Bone Marrow Transplant Infection
About this trial
This is an interventional treatment trial for Viral Infections
Eligibility Criteria
Recipient Inclusion Criteria at the Time of Initial VST Infusion and Subsequent Infusions:
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:
- Prophylaxis for patients at risk of EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3.
- 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.
- 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
- Patients with other uncontrolled infections.
- Patients who received ATG, Campath, Basiliximab or other T cell immunosuppressive monoclonal antibodies within 28 days prior to VST infusion.
- Received donor lymphocyte infusion or other cellular therapies (with the exception of allogeneic cells related to transplantation) within 28 days prior to VST infusion.
- Evidence of acute GVHD grades II-IV.
- Active and uncontrolled relapse of malignancy.
- Patients with Grade ≥ 3 hyperbilirubinemia.
- Patients who have received investigational (IND) product within 28 days prior VST infusion.
Sites / Locations
- Childrens National Medical Center
Arms of the Study
Arm 1
Experimental
Prophylactic and treatment
Virus Specific T cells (VSTs) for prophylactic and treatment of active viral infection(s) after HSCT. 3 different dose levels starting with 1 x 10E7 /m2 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 2 x 10E7/m2 and a final dose 5 x 10E7 VSTs/m2