Table 1.
Patient demographics and baseline clinical characteristics (safety analysis set, n = 16)
| Safety analysis set (n = 16) | |
|---|---|
| Disease type by investigator, n (%) | |
| DLBCL | 14 (87.5)a |
| PMBCL | 1 (6.3) |
| TFL | 1 (6.3) |
| HGBCL | 0 (0.0) |
| Age | |
| Median (range), years | 58 (44–70) |
| ≥ 65 years, n (%) | 5 (31.3) |
| Sex, n (%) | |
| Male | 11 (68.8) |
| Female | 5 (31.3) |
| Body weight, median (range), kg | 63.6 (44.6–78.2) |
| ECOG PS, n (%) | |
| 0 | 12 (75.0) |
| 1 | 4 (25.0) |
| Disease stage at study entryb, n (%) | |
| I | 4 (25.0) |
| II | 4 (25.0) |
| III | 1 (6.3) |
| IV | 7 (43.8) |
| Bulky disease (≥ 1 lesion of 10 cm in diameter), n (%) | |
| Yes | 1 (6.3) |
| No | 15 (93.8) |
| Tumor burden (SPD) for target lesions, mm2 | |
| Mean (SD) | 4544.9 (6748.17) |
| Median (range) | 1991.5 (288–26,360) |
| International Prognostic Index, n (%) | |
| 0 | 3 (18.8) |
| 1 | 4 (25.0) |
| 2 | 3 (18.8) |
| 3 | 4 (25.0) |
| 4 | 2 (12.5) |
| 5 | 0 (0.0) |
| CD19 positivity at baseline, n (%) | |
| Yes | 13 (81.3) |
| No | 1 (6.3) |
| Missing | 2 (12.5) |
| ≥ 3 lines of prior chemotherapy, n (%) | 12 (75.0) |
| Refractory subgroup, n (%) | |
| Primary refractory | 0 (0.0) |
| Refractory to second- or subsequent-line therapy | 10 (62.5) |
| Relapse after ASCT | 6 (37.5) |
Baseline value is defined as the last value taken before conditioning chemotherapy
ASCT autologous stem cell transplantation, CD cluster of differentiation, DLBCL diffuse large B-cell lymphoma, ECOG PS Eastern Cooperative Oncology Group performance status, HGBCL high-grade B-cell lymphoma, PMBCL primary mediastinal large B-cell lymphoma, SD standard deviation, SPD sum of the products of the greatest diameters, TFL transformed follicular lymphoma
aOne patient was confirmed as having HGBCL by central read assessment
bCotswolds modification of the Ann Arbor staging system