Autologous CD4 T-Cells in HIV (C34-CXCR4)

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

November 30, 2019

Study Completion Date

March 31, 2020

Conditions
Hiv
Interventions
BIOLOGICAL

Autologous CD4 T-Cells

all participants will receive a single infusion of C34-CXCR4-modified CD4+ T-cells at one of 3 dose levels. The first 3 subjects will receive dose level 1 of 0.8-1x109 transduced CD4+T-cells. Provided no dose limiting toxicity (DLT) is seen at the first dose level, the next 3 subjects will receive infusion at the 2nd dose level of 2.4-3x109 transduced CD4+ T-cells. If no DLT occurs at that dose, the final 3 subjects will receive the 3rd dose level of 0.8-1x1010 transduced CD4+ T-cells. In the event of a DLT (grade 3 or higher unexpected, related AE) recruitment will be paused pending DSMB decision

Trial Locations (1)

19104

University of Pennsylvania, Philadelphia

All Listed Sponsors
lead

University of Pennsylvania

OTHER

NCT03020524 - Autologous CD4 T-Cells in HIV (C34-CXCR4) | Biotech Hunter | Biotech Hunter