Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

October 31, 2017

Study Completion Date

October 16, 2018

Conditions
EBVCMVAdenovirus
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

20010

Childrens National Medical Center, Washington D.C.

All Listed Sponsors
lead

Catherine Bollard

OTHER

NCT01945814 - Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL) | Biotech Hunter | Biotech Hunter