TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allog
The purpose of this study is to use VSTs (virus-specific T cells) from a donor that is a partial HLA (human leukocyte antigen) match with the patient to treat viral infections after an allogeneic hematopoietic stem cell transplant (HSCT). These cells may also have value in CAR-T recipients who have received a product t
| Condition(s) | Viral Infection |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The purpose of this study is to use VSTs (virus-specific T cells) from a donor that is a partial HLA (human leukocyte antigen) match with the patient to treat viral infections after an allogeneic hematopoietic stem cell transplant (HSCT). These cells may also have value in CAR-T recipients who have received a product that depletes virus specific T cells. The patient must have had a myeloablative or non-myeloablative allogeneic HSCT using either bone marrow, single/double umbilical cord blood, or peripheral blood stem cells (PBSC) or CAR T cell product targeting an antigen expressed on virus specific T cells. After a transplant, while the immune system grows back, the patient is at risk for infection. Some viruses can stay in the body for life and are normally controlled by a healthy immune |
| Who can participate | Inclusion Criteria: 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood. Or Received CAR-T cells targeting an antigen expressed on normal virus specific T cells 2. Treatment for Infection/Disease will fall into one of 3 categories (options): * Option 1: Persistent, increasing or recurrent infections despite 7 days of standard therapy; * a. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet, letermovir or cidofovir. 56, 57 * i. CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histol |
| Sex | All |
| Lead sponsor | Baylor College of Medicine |
| Locations | Houston, Texas, United States; Houston, Texas, United States |
| Start date | 2021-03-08 |
| NCT ID | NCT04013802 |
| Official listing | https://clinicaltrials.gov/study/NCT04013802 |