Table 1.
Baseline Patient and Disease Characteristics
| Characteristic | Number (%) |
|---|---|
|
| |
| No. of patients | 28 |
|
| |
| Disease type - no. (%) | |
| DLBCL | 17 (61) |
| HGBCL | 4 (14) |
| Transformed indolent B cell lymphoma | 7 (25) |
|
| |
| Age | |
| Median (range) - yr. | 65 (48 – 86) |
| ≥65 yr. - no. (%) | 13 (46) |
|
| |
| Male sex - no. (%) | 15 (54) |
|
| |
| Prior therapies - no. (%) | |
| Primary refractory disease | 24 (86) |
| Refractory to last line of therapy pre-apheresis | 25 (89) |
| Prior autologous SCT | 3 (11) |
| Prior CD19 directed therapy | 3 (11) |
|
| |
| Prior lines of therapy | |
| Median (range) | 1 (1 – 6) |
| ≥2 prior lines of therapy - no. (%) | 11 (39) |
|
| |
| Genomics* | |
| Double-hit | 7 (30) |
| TP53 mutated | 7 (30) |
| Double-hit or TP53 mutated | 12 (52) |
|
| |
| Bridging therapy - no. (%) | 25 (89) |
| Chemotherapy | 19 (68) |
| Radiation | 6 (21) |
|
| |
| Metabolic tumor volume, median (range) - ml | |
| At enrollment | 51.8 (0.5 – 831.9) |
| At lymphodepleting chemotherapy** | 37.1 (0 – 413.3) |
|
| |
| Median tumor burden at lymphodepleting chemotherapy¶ (range) - mm2 | 1,430 (0 – 8,611) |
|
| |
| LDH > ULN at enrollment - no. (%) | 14 (50) |
| Median LDH (range), U/l | 349 (152 – 3,754) |
|
| |
| LDH > ULN at lymphodepleting chemotherapy - no. (%) | 11 (39) |
| Median LDH (range), U/l | 181 (141 – 1,073) |
|
| |
| CRP at lymphodepleting chemotherapy | |
| Median CRP (range), mg/dL | 0.30 (0.07 – 18.70) |
Abbreviations: DLBCL, diffuse large B-cell lymphoma; HGBCL, high grade B-cell lymphoma; PMBCL, primary mediastinal B-cell lymphoma; SCT, stem cell transplant; SPD: sum of the products of diameters; LDH: lactate dehydrogenase; ULN, upper limit of normal; CRP, C-reactive protein.
Available in 23 patients.
Restaged after bridging (if administered) and immediately prior to lymphodepleting chemotherapy and prior to CAR T cell infusion.
Tumor burden was determined on the basis of the sum of product diameters of the target lesions, according to the Cheson criteria41.