Allogeneic Virus-specific T Cell Lines (VSTs)

Plain-language summary

This study examines the use of virus-specific T cells (VSTs) to treat viral infections such as EBV, CMV, and/or adenovirus after an allogeneic stem cell transplant. Patients who have had a prior allogeneic stem cell transplant and have persistent or relapsed viral infections may take part. The study was conducted in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Catherine Bollard

Intervention

VSTs

Start date

10/28/2014

Estimated completion

1/3/2018

Countries

United States

Related genes

Locations

• Washington D.C., United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Received prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, single/double cord blood or PBSC
2. Cells administered as;

   1. Treatment of persistent or relapsed reactivation or infection
   2. Early treatment for single or multiple infections with EBV, CMV and/or adenovirus
3. Steroids less or equal to 0.5 mg/kg/day prednisone

5)Bilirubin \<3x, AST \<3x, Serum creatinine \<2x upper limit of normal, Hgb \>8.0, plts \>20 6) Pulse oximetry of \> 90% on room air 7) Available VSTs 8) Negative pregnancy test (if female of childbearing potential after reduced intensity conditioning) 9) Patient or parent/guardian capable of providing informed consent.

Exclusion Criteria:

1. Received ATG, Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.
2. Patients with other uncontrolled infections
3. Received donor lymphocyte infusion in last 28 days
4. Evidence of GVHD \> or equal to grade 2
5. Active and uncontrolled relapse of malignancy