Baseline characteristics
| . | NKTR-255 + CAR19-22 (n = 9) . | CAR19-22 historical controls (n = 8) . |
|---|---|---|
| Age (median, y) | 36 | 49 |
| Hispanic | 5 (56%) | 5 (62%) |
| Ph-negative | 8 (89%) | 2 (25%) |
| Prior lines of therapy (range) | 3 (1-5) | 4 (2-10) |
| CD19 expression | 9 (100%) | 8 (100%) |
| CD22 expression∗ | 7 (78%) | 7 (88%) |
| Prior blinatumomab | 5 (56%) | 5 (63%) |
| Prior inotuzumab | 4 (44%) | 4 (50%) |
| Prior CAR19† | 1 (11%) | 1 (13%) |
| Prior HCT | 5 (56%) | 6 (75%) |
| Low disease burden | 8 (89%) | 8 (100%) |
| CNS disease | 3 (33%) | 4 (50%) |
| CAR19-22 dose | ||
| 1 × 106 cells per kg | 0 | 3 (37%) |
| 3 × 106 cells per kg | 9 (100%) | 5 (63%) |
| CRS related to CAR19-22 | ||
| Grade 1 | 4 (44%) | 1 (13%) |
| Grade 2 | 0 (0%) | 3 (38%) |
| ICANS related to CAR19-22 | ||
| Grade 1 | 0 (0%) | 1 (13%) |
| NKTR-255 dose | ||
| 1.5 μg/kg | 3 (33%) | — |
| 3.0 μg/kg | 4 (44%) | — |
| 6.0 μg/kg | 2 (22%) | — |
| Number of NKTR-255 infusions (median, range) | 2 (1-5) | — |
| . | NKTR-255 + CAR19-22 (n = 9) . | CAR19-22 historical controls (n = 8) . |
|---|---|---|
| Age (median, y) | 36 | 49 |
| Hispanic | 5 (56%) | 5 (62%) |
| Ph-negative | 8 (89%) | 2 (25%) |
| Prior lines of therapy (range) | 3 (1-5) | 4 (2-10) |
| CD19 expression | 9 (100%) | 8 (100%) |
| CD22 expression∗ | 7 (78%) | 7 (88%) |
| Prior blinatumomab | 5 (56%) | 5 (63%) |
| Prior inotuzumab | 4 (44%) | 4 (50%) |
| Prior CAR19† | 1 (11%) | 1 (13%) |
| Prior HCT | 5 (56%) | 6 (75%) |
| Low disease burden | 8 (89%) | 8 (100%) |
| CNS disease | 3 (33%) | 4 (50%) |
| CAR19-22 dose | ||
| 1 × 106 cells per kg | 0 | 3 (37%) |
| 3 × 106 cells per kg | 9 (100%) | 5 (63%) |
| CRS related to CAR19-22 | ||
| Grade 1 | 4 (44%) | 1 (13%) |
| Grade 2 | 0 (0%) | 3 (38%) |
| ICANS related to CAR19-22 | ||
| Grade 1 | 0 (0%) | 1 (13%) |
| NKTR-255 dose | ||
| 1.5 μg/kg | 3 (33%) | — |
| 3.0 μg/kg | 4 (44%) | — |
| 6.0 μg/kg | 2 (22%) | — |
| Number of NKTR-255 infusions (median, range) | 2 (1-5) | — |
Ph, Philadelphia chromosome.
Two patients in the NKTR-255 cohort and 1 in the control group did not have a formal CD22 evaluation.
One patient in the NKTR-255 cohort previously received the same CAR19-22 and achieved CR and underwent allogeneic HCT before eventual relapse and was retreated with CAR19-22 + NKTR-255 after HCT. One patient in the control cohort received an investigational CAR19 product twice before CAR19-22.