Comparison of CD3+, CD4+, CD8+, and CD3+CD45RA–CCR-7– T-cell recovery between dose levels by month after SCT
. | CD3+ . | . | . | . | . | CD4+ . | . | . | . | . | CD8+ . | . | . | . | . | Effector memory cells . | . | . | . | . | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Dose level 1 . | . | Dose level 2 . | . | . | Dose level 1 . | . | Dose level 2 . | . | . | Dose level 1 . | . | Dose level 2 . | . | . | Dose level 1 . | . | Dose level 2 . | . | . | ||||||||||||||||
| Mo . | No. pts . | Median, cells/μL . | No. pts . | Median, cells/μL . | P . | No. pts . | Median, cells/μL . | No. pts . | Median, cells/μL . | P . | No. pts . | Median, cells/μL . | No. pts . | Median, cells/μL . | P . | No. pts . | Median, cells/μL . | No. pts . | Median, cells/μL . | P . | ||||||||||||||||
| 1 | 7 | 0 | 6 | 4 | .215 | 7 | 0 | 6 | 3.5 | .086 | 7 | 0 | 6 | 6 | .113 | 7 | 0 | 5 | 0 | .807 | ||||||||||||||||
| 2 | 7 | 2 | 6 | 19.5 | .216 | 7 | 0 | 6 | 5 | .276 | 7 | 1 | 6 | 5.5 | .519 | 7 | 0 | 6 | 0 | .402 | ||||||||||||||||
| 3 | 7 | 2 | 6 | 615.5 | .016* | 7 | 1 | 6 | 177 | .059 | 7 | 1 | 6 | 533 | .065 | 7 | 0 | 6 | 438 | .025* | ||||||||||||||||
| 4 | 6 | 111.5 | 6 | 747 | .017* | 6 | 47 | 6 | 303.5 | .017* | 6 | 26 | 6 | 494.5 | .031* | 6 | 0 | 6 | 622.5 | .016* | ||||||||||||||||
| 5 | 6 | 175 | 6 | 900 | .040* | 6 | 92 | 6 | 206.5 | .093 | 6 | 52.5 | 6 | 460.5 | .054 | 6 | 26.5 | 6 | 610 | .022* | ||||||||||||||||
| 6 | 5 | 488 | 5 | 1421 | .129 | 5 | 226 | 5 | 244 | .425 | 5 | 195 | 5 | 850 | .178 | 5 | 68 | 5 | 897 | .066 | ||||||||||||||||
| 7 | 4 | 284.5 | 4 | 479 | .678 | 4 | 110 | 4 | 259.5 | .346 | 4 | 144 | 4 | 319.5 | .494 | 4 | 155.5 | 4 | 353 | .156 | ||||||||||||||||
| 8 | 4 | 410.5 | 2 | 1342.5 | .299 | 4 | 158 | 2 | 572.5 | .299 | 4 | 213.5 | 2 | 761.5 | .518 | 3 | 287 | 2 | 915 | .435 | ||||||||||||||||
| 9 | 3 | 1047 | 2 | 1450 | .787 | 3 | 399 | 2 | 410 | .787 | 3 | 462 | 2 | 1030 | >.999 | 3 | 10 | 2 | 1094.5 | .435 | ||||||||||||||||
. | CD3+ . | . | . | . | . | CD4+ . | . | . | . | . | CD8+ . | . | . | . | . | Effector memory cells . | . | . | . | . | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Dose level 1 . | . | Dose level 2 . | . | . | Dose level 1 . | . | Dose level 2 . | . | . | Dose level 1 . | . | Dose level 2 . | . | . | Dose level 1 . | . | Dose level 2 . | . | . | ||||||||||||||||
| Mo . | No. pts . | Median, cells/μL . | No. pts . | Median, cells/μL . | P . | No. pts . | Median, cells/μL . | No. pts . | Median, cells/μL . | P . | No. pts . | Median, cells/μL . | No. pts . | Median, cells/μL . | P . | No. pts . | Median, cells/μL . | No. pts . | Median, cells/μL . | P . | ||||||||||||||||
| 1 | 7 | 0 | 6 | 4 | .215 | 7 | 0 | 6 | 3.5 | .086 | 7 | 0 | 6 | 6 | .113 | 7 | 0 | 5 | 0 | .807 | ||||||||||||||||
| 2 | 7 | 2 | 6 | 19.5 | .216 | 7 | 0 | 6 | 5 | .276 | 7 | 1 | 6 | 5.5 | .519 | 7 | 0 | 6 | 0 | .402 | ||||||||||||||||
| 3 | 7 | 2 | 6 | 615.5 | .016* | 7 | 1 | 6 | 177 | .059 | 7 | 1 | 6 | 533 | .065 | 7 | 0 | 6 | 438 | .025* | ||||||||||||||||
| 4 | 6 | 111.5 | 6 | 747 | .017* | 6 | 47 | 6 | 303.5 | .017* | 6 | 26 | 6 | 494.5 | .031* | 6 | 0 | 6 | 622.5 | .016* | ||||||||||||||||
| 5 | 6 | 175 | 6 | 900 | .040* | 6 | 92 | 6 | 206.5 | .093 | 6 | 52.5 | 6 | 460.5 | .054 | 6 | 26.5 | 6 | 610 | .022* | ||||||||||||||||
| 6 | 5 | 488 | 5 | 1421 | .129 | 5 | 226 | 5 | 244 | .425 | 5 | 195 | 5 | 850 | .178 | 5 | 68 | 5 | 897 | .066 | ||||||||||||||||
| 7 | 4 | 284.5 | 4 | 479 | .678 | 4 | 110 | 4 | 259.5 | .346 | 4 | 144 | 4 | 319.5 | .494 | 4 | 155.5 | 4 | 353 | .156 | ||||||||||||||||
| 8 | 4 | 410.5 | 2 | 1342.5 | .299 | 4 | 158 | 2 | 572.5 | .299 | 4 | 213.5 | 2 | 761.5 | .518 | 3 | 287 | 2 | 915 | .435 | ||||||||||||||||
| 9 | 3 | 1047 | 2 | 1450 | .787 | 3 | 399 | 2 | 410 | .787 | 3 | 462 | 2 | 1030 | >.999 | 3 | 10 | 2 | 1094.5 | .435 | ||||||||||||||||
Pts indicates patients.
Statistically significant increases in dose level 2 compared with dose level 1.