Table I.
Patient demographics and baseline clinicopathological measurements
| IV | SQ | Cross-Over | Total | |
|---|---|---|---|---|
| Number of Subjects | 19 | 17 | 6 | 41* |
| Age (years) | ||||
| Median | 65.0 | 58.0 | 64.0 | 63.5 |
| Range | (48.0-72.0) | (26.0-76.0) | (50.0-68.0) | (26.0-76.0) |
| Gender | ||||
| Females | 6 (31.6%) | 1 (5.9%) | 0 (0%) | 7 (16.7%) |
| Males | 13 (68.4%) | 16 (94.1%) | 6 (100%) | 35 (83.3%) |
| Number of Prior Therapies | ||||
| 1 | 11 (57.9%) | 14 (82.4%) | 5 (100%) | 30 (73.2%) |
| 2 | 2 (10.5%) | 2 (11.8%) | 0 (0%) | 4 (9.8%) |
| 3+ | 6 (31.6%) | 1 (5.9%) | 0 (0%) | 7 (17.1%) |
| Lymphocyte count (× 109/L) | ||||
| N | 17 | 16 | 5 | 38 |
| Median | 15.8 | 14.1 | 19.9 | 16.8 |
| Range | 4.0-204.2 | 8.9-75.4 | 6.4-268.2 | 4.04-268.2 |
| Baseline Cell Counts (× 109/L) | ||||
| N | 16 | 16 | 3 | 35 |
| TRAIL+CD19+ | ||||
| Median | 0.02 | 0.02 | 0.01 | 0.02 |
| Range | 0.01-0.37 | 0.01-0.08 | 0.01-8.18 | 0.01-8.18 |
| CD3-CD16+CD56+ | ||||
| Median | 0.19 | 0.20 | 0.25 | 0.20 |
| Range | 0.01-0.48 | 0.05-0.43 | 0.04-0.29 | 0.01-0.48 |
| CD3+CD80- | ||||
| Median | 1.26 | 1.06 | 2.61 | 1.09 |
| Range | 0.20-4.70 | 0.44-4.83 | 0.46-2.68 | 0.20-4.83 |
| CD3+CD38+ | ||||
| Median | 0.13 | 0.19 | 0.33 | 0.19 |
| Baseline MFI | ||||
| N | 17 | 17 | 4 | 38 |
| CD20 Median | 15.7 | 12.6 | 178.7 | 14.5 |
| Range | 3.8-70.5 | 5.6-64.4 | 12.5-1537.0 | 3.8-1537.0 |
| CD86 Median | 38.6 | 40.0 | 43.3 | 39.9 |
| Range | 33.1-74.4 | 32.2-54.0 | 29.1-65.1 | 29.1-74.4 |
*
One patient who participated in the single IV CpG dose level 3 cohort also participated in the cross over cohort.