27
Participants
Start Date
February 28, 2014
Primary Completion Date
October 31, 2017
Study Completion Date
October 16, 2018
CTL for CMV seropositive donors
CTL for CMV seropositive donors-Allogeneic Multivirus Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV seropositive donors dose is depending on the toxicity outcome, the maximum sample size for the this phase I portion of the trial is 14. Upon the completion of mCTL safety evaluation, additional 7 patients will be accrued at the MTD level to evaluate its antiviral activity.
CTL for CMV naïve donors
CTL for CMV naïve donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV naïve donors dose is depending on the toxicity outcome, the maximum sample size for the this phase I portion of the trial is 14. Upon the completion of mCTL safety evaluation, additional 7 patients will be accrued at the MTD level to evaluate its antiviral activity.
Childrens National Medical Center, Washington D.C.
Catherine Bollard
OTHER