Table 2 Toxicity and clinical response to treatment with the HD-CAR-1 product
UPN | Age | Gender | Disease | CART dose [CARTs/m2] | CRS grade | ICANS | Infection | Best response | Response at EOS | alloSCT after CARTs | Progression of disease/death [day after CARTs] |
|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 32 | F | B-ALL | 1 × 106 | I | – | RSV | PD | PD | – | 28 (CSF: 13 blasts /µl)/254 |
2 | 21 | M | Pre-B-ALL | 1 × 106 | – | – | – | CR MRD +  | CR MRD +  | Yes | 119 (BM: 8% blasts)/268 |
3†| 67 | F | B-ALL | 1 × 106 | – | – | – | CR MRD + (day 28) | n.r | – | 56 (BM: 52% blasts)/76 |
4 | 32 | F | B-ALL | 5 × 106 | – | – | – | CR MRD − | CR MRD − | – | – |
5 | 63 | M | Pre-B-ALL | 5 × 106 | – | – | Staph. epi | CR MRD − | CR MRD +  | – | 146 (extramedullary: malignant ascites) |
6 | 28 | F | B-ALL | 5 × 106 | I | – | – | CR MRD − | CR MRD-(metabolic CR) | – | 120 (extramedullary: right mamma) |
7 | 67 | F | MPAL | 20 × 106 | – | – | – | CR MRD − | CR MRD +  | – | – |
8†| 36 | F | Pre-B-ALL | 20 × 106 | II | – | – | PD | n.r | Yes | 23 (BM: 100% blast infiltration)/58 |
9 | 45 | M | B-ALL | 20 × 106 | – | – | – | CR MRD − | CR MRD − | – | 189 (CSF: 50–60% blasts) |
10 | 47 | F | B-ALL | 20 × 106 | – | – | – | CR MRD +  | PD | Yes | 93 (BM: 9% blasts) |
11 | 37 | M | B-ALL | 50 × 106 | – | – | Respiratory* | CR MRD − | CR MRD − |  |  |
12†| 36 | M | B-ALL | 50 × 106 | II | – | E. coli sepsis | SD (day 26) | n.r | – | –/39 (TRM: septic MOV) |
13 | 32 | M | B-ALL | 50 × 106 | – | – | Respiratory* | CR MRD − | CR MRD-(metabolic CR) | – | – |