Table 2.
Patient characteristics, responses and outcomes for enrolled patients with B-ALL
| Patient ID | Dose level | Age/sex | Previous allo-HCT | Previous anti-CD19/CD22 | Marrow disease burden | Extra-medullary disease | CNS disease | Maximum CRS | Maximum NE | Best response (PFS) | CD19+ blast percentage at progressiona | CD19 site density at progressionb | CD22+ blast percentage at progressiona | CD22 site density at progression |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SA4 | 1 | 50/F | Matched related donor | – | – | Yes | Active | 2 | 0 | CRi (7+) | – | – | – | – |
| SA7 | 1 | 35/F | Haplo-identical | – | MRDc | – | Previous | 1 | 0 | CR (3) | 95%d | – | 95%d | – |
| SA8 | 2 | 68/M | MUD | Blinatumomab | – | Yes | Previous | 1 | 2 | CRi (12) | – | – | – | – |
| SA9 | 2 | 47/M | MUD | JCAR15e | MRDc | – | Previous | 0 | 0 | CRi (1) | 100% | NA | ||
| SA13 | 2 | 58/M | – | Blinatumomab/inotuzumab | >5% | Yes | – | 4 | 4 | CRi (5) | 0% | 64 | 90 | 6,016 |
| SA24 | 2 | 35/M | – | Blinatumomab | >5% | – | – | 2 | 0 | CRi (3) | 0% | 0 | 90 | 5,915 |
| SA26 | 2 | 26/M | Matched related donor | Blinatumomab/inotuzumab | – | Yes | – | 1 | 0 | CR (10+) | – | – | – | – |
| SA29 | 2 | 27/M | MUD | Blinatumomab/inotuzumab | – | Yes | Previous | 1 | 0 | PR (3) | N/Ad | – | – | – |
| SA30 | 2 | 59/M | MUD | Blinatumomab/inotuzumab | MRDc | – | – | 2 | 0 | CR (9+) | – | – | – | – |
| SA32 | 2 | 36/F |
First: matched related donor Second: MUD |
– | >5% | – | Previous | 2 | 0 | CRi (6) | 20% | – | 90 | – |
| SA33 | 2 | 26/M | – | – | >5% | – | Previous | 1 | 3 | CRi (2) | 0% | 82 | 90 | 9,031 |
| SA34 | 2 | 48/F | Matched related donor | Blinatumomab | >5% | Yes | – | 0 | 0 | CR (6) | 100% | 17,944 | 90 | 1,726 |
| SA35 | 2 | 31/M | – | Blinatumomab/inotuzumab | MRDc | – | Previous | 2 | 1 | CRi (9+) | – | – | – | – |
| SA36 | 2 | 53/F | MMURD | – | – | Yes | Active | 0 | 0 | PR (3) | 80% | 94 | 90 | 7,112 |
| SA37 | 2 | 33/M | First: matched related donor Second: MUD | Blinatumomab/inotuzumab | – | Yes | Previous | 0 | 0 | CRi (2) | >90% | 16,074 | 90 | 3,815 |
| SA38 | 2 | 48/M | MUD | – | >5% | – | – | 2 | 0 | CR (6+) | – | – | – | – |
| SA39 | 2 | 48/M | – | Blinatumomab | >5% | – | – | 2 | 3 | CR (6+) | – | – | – | – |
aAntigen status for leukemia determined by standard flow cytometry. bCD19 positivity by site density was >3,000 molecules per cell. cMRD at 10−4. dFor patients S7 and S29, antigen status at relapse was determined by IHC. Patient S29 was determined CD19+ by an outside pathologist. eJCAR15, investigational CAR19. The + symbol indicates an ongoing response. MMURD, mismatched unrelated donor; MUD, matched unrelated donor.