Table 1. Baseline characteristics.
Total (n=22) | InstanCART group (n=7) | TraditionCART group (n=15) | P value | |
Age, median (range) | 62.5 (45.0–78.0) | 62.0 (45.0–78.0) | 63.0 (54.0–73.0) | 0.68 |
Male sex, no. (%) | 8 (36) | 2 (29) | 6 (40) | 0.97 |
Immunoglobulin subtype, no. (%) | 0.44 | |||
IgA | 11 (50) | 2 (29) | 9 (60) | |
IgG | 6 (27) | 3 (43) | 3 (20) | |
IgD | 1 (5) | 1 (14) | 0 | |
Light chain only | 4 (18) | 1 (14) | 3 (20) | |
Years since diagnosis, median (range) | 2.9 (0.8–14.7) | 3.4 (0.8–13.0) | 2.5 (1.2–14.7) | 0.96 |
Prior lines of therapy, median (range) | 3 (2–7) | 3 (2–7) | 3 (2–7) | 0.79 |
Triple-class refractory, no. (%) | 15 (68) | 5 (71) | 10 (67) | 1.00 |
Previous autologous stem-cell transplantation, no. (%) | 9 (41) | 4 (57) | 5 (33) | 0.55 |
Soft tissue plasmacytoma, no. (%) | 13 (59) | 4 (57) | 9 (60) | 1.00 |
Extramedullary disease | 8 (36) | 3 (43) | 5 (33) | 0.96 |
Cytogenetic risk category, no. (%) | ||||
High risk cytogenetic profile | 11 (50) | 4 (57) | 7 (47) | 1.00 |
Deletion 17p | 7 (32) | 1 (14) | 6 (40) | |
t(4;14) | 6 (27) | 3 (43) | 3 (20) | |
amp(1q) | 13 (59) | 4 (57) | 9 (60) | |
t(11;14) | 4 (18) | 1 (14) | 3 (20) | |
Absolute neutrophil count, no. (%) | 1.00 | |||
≥1.0×109/L | 19 (86) | 6 (86) | 13 (87) | |
<1.0×109/L | 3 (14) | 1 (14) | 2 (13) | |
Hemoglobin, no. (%) | 0.30 | |||
≥100 g/L | 8 (36) | 1 (14) | 7 (47) | |
80–<100 g/L | 9 (41) | 4 (57) | 5 (33) | |
<80 g/L | 5 (23) | 2 (29) | 3 (20) | |
Platelets, no. (%) | 0.80 | |||
≥100×109/L | 11 (50) | 4 (57) | 7 (47) | |
50–<100×109/L | 5 (23) | 1 (14) | 4 (27) | |
<50×109/L | 6 (27) | 2 (29) | 4 (27) | |
Creatinine clearance in mL/min, median (range) | 74.2 (23.7–151.1) | 84.5 (23.7–151.1) | 60.1 (33.5–124.1) | 0.18 |
Bone marrow plasma cells burden, % (range) | 18.0 (0–95.5) | 37.0 (0–95.5) | 16.0 (1.2–14.7) | 0.21 |
ECOG performance-status score, no. (%) | 0.21 | |||
0 | 6 (27) | 3 (43) | 3 (20) | |
1 | 7 (32) | 3 (43) | 4 (27) | |
2 | 3 (14) | 1.0 (14) | 2 (13) | |
3 | 4 (18) | 0 | 4.0 (27) | |
4 | 2 (9) | 0 | 2 (13) | |
Bridging therapy, no. (%) | 10.0 (45.5) | 4.0 (57.1) | 6.0 (40.0) | 0.77 |
ECOGEastern Cooperative Oncology GroupInstanCARTinstant manufacturing platformTraditionCARTtraditional manufacturing process