CD4ζ-modified T-cell survival and gene expression in peripheral blood mononuclear cells (PBMCs).

Gene-modified T-cell infusion was administered at week 0, and patients were followed for at least 8 weeks after infusion. (A) Survival of CD4ζ-modified T cells in peripheral blood as measured by quantitative DNA PCR analysis for CD4ζ in the cells only (▴) and cells + IL-2 (▪) treatment cohorts through 8 weeks of follow-up. There were no statistically significant differences between cohorts at any time point after infusion (P = .35, week 2; P = .49, week 4;P = .93, week 8). (B) Immunoselected populations of CD4⁺ (▪) and CD8⁺ (•) T cells in peripheral blood were analyzed for the presence of CD4ζ by DNA PCR and compared with the presence of CD4ζ in the bulk population (▴). The results confirmed the persistence of both gene-modified CD4⁺ and CD8⁺ T cells in 6 of 6 patients analyzed for at least 8 weeks. Results of 1 representative patient (J233) out of a total of 6 analyzed are shown. (C) Persistent, relatively stable expression of the CD4ζ gene was confirmed for at least 16 weeks by CD4ζ RNA RT-PCR analysis of PBMCs in 6 patients (G251, T253, Y254, Q202, Y292, and J233).