Results of repeated infusions of receptor-modified syngeneic T cells.

(A) Persistence of CD4/CD3-ζ–modified CD8⁺ T cells in the 17 patients who received gene-modified CD8⁺T cells without interleukin 2 (IL-2) (closed squares and solid line) and in the 4 patients who received gene-modified CD8⁺ T cells with IL-2 (open circles and broken line). Quantitative competitive DNA polymerase chain reaction (PCR) for the CD4/CD3-ζ gene was performed on peripheral blood mononuclear cells (PBMC), and results were expressed as log₁₀ DNA copies per million CD8⁺T cells. The closed triangles spaced at 56-day intervals represent the timing of each cell infusion with and without IL-2. Data were modeled for individual patients, and a mixed-model analysis was used to derive the mean of each time point for the 2 groups. SEs are between 0.40 and 0.52 at each point. (B) Persistence of CD4/CD3-ζ–modified CD4⁺ T cells (closed squares and solid line) and CD8⁺ T cells (open circles and broken line) in the 14 patients who received modified CD4⁺ and CD8⁺ cells without IL-2. Data were modeled as described for Figure 1A and results expressed as log₁₀ DNA copies per million CD4⁺ or CD8⁺ cells. The closed triangles spaced at 14-day intervals represent the timing of the 3 cell infusions. SEs are between 0.02 and 0.03 at each point. (C) Mean plasma human immunodeficiency virus (HIV) RNA levels in recipients of modified CD8⁺ T-cell infusions (closed squares and solid line, n = 17) and in recipients of unmodified CD8⁺ T cells (open circles and broken line, n = 9). Data were modeled as described for Figure 1A and results expressed as log₁₀ HIV RNA copies per milliliter. Closed triangles represent the timing of cell infusions. P = .29 for the differences between the slopes of the 2 curves estimated with an interval-adjusted linear mixed model. (D) Mean CD4⁺ T lymphocyte counts in recipients of modified CD8⁺ T-cell infusions (closed squares and solid line, n = 17) and in recipients of unmodified CD8⁺ T cells (open circles and broken line, n = 9). Data were modeled as described for Figure 1A and results expressed as cells per milliliter. Closed triangles represent the timing of cell infusions. P = .89 for the difference between the slopes of the 2 curves estimated with an interval-adjusted linear mixed model as described for Figure 1C.