Skip to main content
. Author manuscript; available in PMC: 2014 Sep 6.
Published in final edited form as: N Engl J Med. 2014 Mar 6;370(10):901–910. doi: 10.1056/NEJMoa1300662

Table 1.

Patient Demographics and Cell Manufacturing.*

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.