Table 1.
Patient demographics and disease characteristics in safety analysis set at baseline.
| DL1 (3 × 107 cells) | DL2 (1 × 108 cells) | DL3 (3 × 108 cells) | DL4 (9 × 108 cells) | Total | |
|---|---|---|---|---|---|
| N = 3 | N = 3 | N = 6 | N = 4 | N = 16 | |
| Median age, y (range) | 59.0 (58–64) | 60.0 (54–65) | 61.0 (53–73) | 70.0 (66–77) | 63.0 (53–77) |
| Sex at birth, male, n (%) | 3 (100.0) | 3 (100.0) | 6 (100.0) | 2 (50.0) | 14 (87.5) |
| Metastatic disease, n (%) | 3 (100.0) | 3 (100.0) | 6 (100.0) | 4 (100.0) | 16 (100.0) |
| Prior anticancer therapies, n (%) | |||||
| Systemic therapy | 3 (100.0) | 3 (100.0) | 6 (100.0) | 4 (100.0) | 16 (100.0) |
| Radiotherapy | 1 (33.3) | 2 (66.7) | 4 (66.7) | 4 (100.0) | 11 (68.8) |
| Surgery | 3 (100.0) | 3 (100.0) | 5 (83.3) | 4 (100.0) | 15 (93.8) |
| Median prior lines of systemic therapy, n (range) | 2 (1–3) | 3 (2–4) | 3 (1–5) | 3 (2–6) | 3 (1–6) |
| Median time from diagnosis, y (range) | 3.4 (2.5–6.3) | 2.7 (0.7–3.3) | 5.1 (2.5–6.3) | 10.5 (5.1–24.0) | 4.9 (0.7–24.0) |
| IMDC category at screening, n (%) | |||||
| Favorable | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Intermediate | 3 (100.0) | 3 (100.0) | 3 (50.0) | 1 (25.0) | 10 (62.5) |
| Poor | 0 (0.0) | 0 (0.0) | 3 (50.0) | 3 (75.0) | 6 (37.5) |
| eGFR <60 mL/min/1.73 m2, n (%) | 2 (66.7) | 1 (33.0) | 1 (16.7) | 2 (50.0) | 6 (37.5) |
Abbreviations: DL, dose level; eGFR, estimated glomerular filtration rate; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium.