Subject demographics and baseline characteristics
| . | Part 1 . | Part 2 . | ||||
|---|---|---|---|---|---|---|
| . | Cohort 1 (0.1 × 3)/0.5 mg/kg (n = 3) . | Cohort 2 (0.5 × 3)/1.5 mg/kg (n = 3) . | Cohort 3 (3.0 × 3)/7.0 mg/kg (n = 6) . | (3.0 × 3)/ 7.0 mg/kg (n = 18) . | MAD* (3.0 × 3)/ 7.0 mg/kg (n = 24) . | All patients (N = 30) . |
| Median age, y (min, max) | 29.0 (25, 73) | 34.0 (33, 53) | 36.0 (26, 49) | 27.5 (18, 52) | 32.0 (18, 52) | 33.5 (18, 73) |
| Sex | ||||||
| Male | 2 (66.7) | 2 (66.7) | 5 (83.3) | 11 (61.1) | 16 (66.7) | 20 (66.7) |
| Female | 1 (33.3) | 1 (33.3) | 1 (16.7) | 7 (38.9) | 8 (33.3) | 10 (33.3) |
| Prior therapies, no. (%) | ||||||
| 3 | 0 | 0 | 0 | 14 (77.8) | 14 (58.3) | 14 (46.7) |
| 4 | 1 (33.3) | 1 (33.3) | 3 (50.0) | 2 (11.1) | 5 (20.8) | 7 (23.3) |
| 5 | 0 | 1 (33.3) | 2 (33.3) | 0 | 2 (8.3) | 3 (10.0) |
| 6 | 1 (33.3) | 1 (33.3) | 1 (16.7) | 1 (5.6) | 2 (8.3) | 4 (13.3) |
| 7 | 1 (33.3) | 0 | 0 | 1 (5.6) | 1 (4.2) | 2 (6.7) |
| Prior autologous stem cell transplant | 2 (66.7) | 3 (100.0) | 4 (66.7) | 3 (16.7) | 7 (29.2) | 12 (40.0) |
| . | Part 1 . | Part 2 . | ||||
|---|---|---|---|---|---|---|
| . | Cohort 1 (0.1 × 3)/0.5 mg/kg (n = 3) . | Cohort 2 (0.5 × 3)/1.5 mg/kg (n = 3) . | Cohort 3 (3.0 × 3)/7.0 mg/kg (n = 6) . | (3.0 × 3)/ 7.0 mg/kg (n = 18) . | MAD* (3.0 × 3)/ 7.0 mg/kg (n = 24) . | All patients (N = 30) . |
| Median age, y (min, max) | 29.0 (25, 73) | 34.0 (33, 53) | 36.0 (26, 49) | 27.5 (18, 52) | 32.0 (18, 52) | 33.5 (18, 73) |
| Sex | ||||||
| Male | 2 (66.7) | 2 (66.7) | 5 (83.3) | 11 (61.1) | 16 (66.7) | 20 (66.7) |
| Female | 1 (33.3) | 1 (33.3) | 1 (16.7) | 7 (38.9) | 8 (33.3) | 10 (33.3) |
| Prior therapies, no. (%) | ||||||
| 3 | 0 | 0 | 0 | 14 (77.8) | 14 (58.3) | 14 (46.7) |
| 4 | 1 (33.3) | 1 (33.3) | 3 (50.0) | 2 (11.1) | 5 (20.8) | 7 (23.3) |
| 5 | 0 | 1 (33.3) | 2 (33.3) | 0 | 2 (8.3) | 3 (10.0) |
| 6 | 1 (33.3) | 1 (33.3) | 1 (16.7) | 1 (5.6) | 2 (8.3) | 4 (13.3) |
| 7 | 1 (33.3) | 0 | 0 | 1 (5.6) | 1 (4.2) | 2 (6.7) |
| Prior autologous stem cell transplant | 2 (66.7) | 3 (100.0) | 4 (66.7) | 3 (16.7) | 7 (29.2) | 12 (40.0) |
MTD was not reached.