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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

February 15, 2017

Primary Completion Date

March 31, 2026

Study Completion Date

November 30, 2026

Conditions
Viral InfectionsBone Marrow Transplant Infection
Interventions
BIOLOGICAL

Virus Specific T cells (VSTs)

"This Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors.~In this trial, we will utilize a rapid generation protocol for broad spectrum multivirus-specific T cells for infusion to recipients of allogeneic hematopoietic stem cell transplant (HSCT), who are at risk of developing EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3, or with PCR/culture confirmed active infection(s) of 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). These cells will be derived from HSCT donors, and the study agent will be assessed at each dose for evidence of dose-limiting toxicities (DLT)."

Trial Locations (1)

20010

Childrens National Medical Center, Washington D.C.

All Listed Sponsors
lead

Children's National Research Institute

OTHER