Table 1.
Cohort and Patient No.† | Age | Race or Ethnic Group |
Sex | Duration of HIV Infection |
Baseline CD4 T-Cell Count |
Baseline CD4:CD8 T-Cell Ratio |
SB-728-T Dose‡ |
SB-728-T CD3§ |
SB-728-T Cell Modification |
SB-728-T Pentamer Duplication |
---|---|---|---|---|---|---|---|---|---|---|
yr | yr | per mm3 | % | % | per 106 cells | |||||
Cohort 1 | ||||||||||
201 | 54 | White | M | 20.2 | 665 | 1.38 | l.00×l010 | 97.0 | 14.6 | 57,000 |
203 | 50 | Black | M | 21.1 | 659 | 0.59 | 1.08×l010 | 97.7 | 24.5 | 81,000 |
204 | 31 | White | M | 4.3 | 621 | 1.43 | l.00×l010 | 97.9 | 10.9 | 47,000 |
205 | 50 | White | M | 2.4 | 955 | 1.99 | l.00×l010 | 99.1 | 19.1 | 64,000 |
251 | 56 | White | M | 23.1 | 554 | 1.67 | l.00×l010 | 98.6 | 14.4 | 57,000 |
253 | 38 | Asian | M | 2.8 | 997 | 0.98 | l.00×l010 | 94.3 | 18.4 | 61,000 |
Median | 50 | 12.3 | 662 | 1.41 | l.00×l010 | 97.8 | 16.5 | 59,000 | ||
Cohort 2 | ||||||||||
306 | 50 | White | M | 19.1 | 271 | 0.99 | 0.77×l010 | 93.1 | 20.9 | 60,000 |
308 | 37 | Black | M | 13.1 | 328 | 0.78 | 0.50×l010 | 97.5 | 25.3 | 67,000 |
309 | 48 | Asian Indian | F | 2.9 | 341 | 0.54 | 0.80×l010 | 92.3 | 27.7 | 67,000 |
351 | 60 | Black | M | 14.1 | 193 | 1.25 | l.00×l010 | 97.7 | 25.4 | 73,000 |
354 | 41 | Hispanic | M | 15.6 | 220 | 0.50 | 0.90×l010 | 99.3 | 26.7 | 69,000 |
355 | 44 | Black | F | 16.2 | 272 | 0.65 | l.00×l010 | 94.1 | 26.9 | 72,000 |
Median | 46 | 14.9 | 272 | 0.72 | 0.85×l010 | 95.8 | 26.0 | 68,000 |
SB-728-T consists of autologous CD4 T cells in which the CCR5 gene was rendered permanently dysfunctional by zinc-finger nucleases.
Cohort 1 comprised patients with adequate CD4 T-cell recovery after highly active antiretroviral therapy (HAART), defined as those with CD4 T-cell counts above 450 per cubic millimeter at screening, with a documented nadir of not lower than 300 per cubic millimeter. Cohort 2 comprised patients with inadequate CD4 T-cell recovery after HAART, defined as those with CD4 T-cell counts persistently between 200 per cubic millimeter and 500 per cubic millimeter at screening, despite 2 or more years of HAART.
A single dose of autologous CD4 T cells modified at CCR5 by SB-728-T consisted of an infusion of a median of l.00×l010 total cells in cohort 1, and a median of 0.85xl010 in cohort 2.
The percentages of total cells expressing the T-cell marker CD3 are listed.