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New treatment option for Epstein-Barr Virus
Official title R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
ClinicalTrials.gov ID: NCT06926894
What this study is testing
What is Rapidly generated virus specific T (R-MVST) cells?
Rapidly generated virus specific T (R-MVST) cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for epstein-barr virus.
Also referred to as R-MVST infusion, total nucleated cells (TNC).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 26
You may be able to join if
- Children and young adults (3 months to \<26 years) of all ethnic groups will be eligible for the treatment
- Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and/or infection manifesting as end-organ or systemic disease due...
- Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic...
You likely can't join if
- Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy...
- Patients who receive corticosteroids at ≥ 0.5mg/kg prednisone or equivalent.
- Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosuppressive monoclonal antibodies in the last 28...
- Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.
- Patients who received extracorporeal photopheresis within the last 28 days.
- Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to...
See the full eligibility criteria
- Children and young adults (3 months to \<26 years) of all ethnic groups will be eligible for the treatment
- Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and/or infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and...
- Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care...
- Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the...
- Patients who receive corticosteroids at ≥ 0.5mg/kg prednisone or equivalent.
- Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosuppressive monoclonal antibodies in the last 28 days.
- Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.
- Patients who received extracorporeal photopheresis within the last 28 days.
- Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.
- Received donor lymphocyte infusion in last 28 days.
- Evidence of GVHD ≥ grade 2
- Evidence of biopsy-proven acute rejection in SOT recipients
- Active and uncontrolled relapse of malignancy
- Patients who are pregnant, or breastfeeding.
- Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance...
- Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.
- Unable or unwilling to receive infusions at Morgan Stanley Children's Hospital.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 26 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.