Toxicity, CRS management, and response profile in patients with B-ALL
| Category . | Sub-category . | Total subjects treated (n = 20) . | CAR naïve (n = 14) . | CAR pretreated (n = 6) . |
|---|---|---|---|---|
| Dose level | Dose level 1 (3 × 105 CAR T cells/kg) | 4 (20%) | 1 (7.1%) | 3 (50%) |
| Dose level 2 (1 × 106 CAR T cells/kg) | 4 (20%) | 3 (21.4%) | 1 (16.7%) | |
| Dose level 3 (3 × 106 CAR T cells/kg) | 12 (60%) | 10 (71.4%) | 2 (33.3%) | |
| LD | Standard LD | 18 (90%) | 14 (100%) | 4 (66.7%) |
| Intensified LD | 2 (10%) | 0 | 2 (33.3%) | |
| CRS and ICANS* | No CRS | 10 (50%) | 5 (35.7%) | 5 (83.3%) |
| CRS grade 1-2 | 7 (35%) | 6 (42.9%) | 1 (16.7%) | |
| CRS grade 3-4 | 3 (15%) | 3 (21.4%) | 0 | |
| ICANS | 1 (5%) | 0 | 1 (16.7%) | |
| Treatment | Tocilizumab treatment | 6 (30%) | 5 (35.7%) | 1 (16.7%) |
| Corticosteroids treatment† | 4 (20%) | 3 (21.4%) | 1 (16.7%) | |
| Bone marrow response‡ | MRD negative CR | 16 (80%) | 12 (85.7%) | 4 (66.7%) |
| Partial response | 1 (5%) | 1 (7.1%) | 0 | |
| Stable/progressive disease | 3 (15%) | 1 (7.1%) | 2 (33.3%) | |
| Extramedullary response (non-CNS) (n = 8)§ | Complete response | 3 (37.5%) | 3 (50%) | 0 |
| Partial response | 3 (37.5%) | 2 (33.3%) | 1 (50%) | |
| Stable/progressive disease | 2 (25%) | 1 (16.7%) | 1 (50%) | |
| Overall disease response | MRD negative CR | 12(60%) | 10 (71.4%) | 2 (33.3%) |
| Partial response | 3 (15%) | 2 (14.3%) | 1 (7.1%) | |
| Stable/progressive disease | 5 (25%) | 2 (14.3%) | 3 (50%) |
| Category . | Sub-category . | Total subjects treated (n = 20) . | CAR naïve (n = 14) . | CAR pretreated (n = 6) . |
|---|---|---|---|---|
| Dose level | Dose level 1 (3 × 105 CAR T cells/kg) | 4 (20%) | 1 (7.1%) | 3 (50%) |
| Dose level 2 (1 × 106 CAR T cells/kg) | 4 (20%) | 3 (21.4%) | 1 (16.7%) | |
| Dose level 3 (3 × 106 CAR T cells/kg) | 12 (60%) | 10 (71.4%) | 2 (33.3%) | |
| LD | Standard LD | 18 (90%) | 14 (100%) | 4 (66.7%) |
| Intensified LD | 2 (10%) | 0 | 2 (33.3%) | |
| CRS and ICANS* | No CRS | 10 (50%) | 5 (35.7%) | 5 (83.3%) |
| CRS grade 1-2 | 7 (35%) | 6 (42.9%) | 1 (16.7%) | |
| CRS grade 3-4 | 3 (15%) | 3 (21.4%) | 0 | |
| ICANS | 1 (5%) | 0 | 1 (16.7%) | |
| Treatment | Tocilizumab treatment | 6 (30%) | 5 (35.7%) | 1 (16.7%) |
| Corticosteroids treatment† | 4 (20%) | 3 (21.4%) | 1 (16.7%) | |
| Bone marrow response‡ | MRD negative CR | 16 (80%) | 12 (85.7%) | 4 (66.7%) |
| Partial response | 1 (5%) | 1 (7.1%) | 0 | |
| Stable/progressive disease | 3 (15%) | 1 (7.1%) | 2 (33.3%) | |
| Extramedullary response (non-CNS) (n = 8)§ | Complete response | 3 (37.5%) | 3 (50%) | 0 |
| Partial response | 3 (37.5%) | 2 (33.3%) | 1 (50%) | |
| Stable/progressive disease | 2 (25%) | 1 (16.7%) | 1 (50%) | |
| Overall disease response | MRD negative CR | 12(60%) | 10 (71.4%) | 2 (33.3%) |
| Partial response | 3 (15%) | 2 (14.3%) | 1 (7.1%) | |
| Stable/progressive disease | 5 (25%) | 2 (14.3%) | 3 (50%) |
N (%) unless otherwise specified.
Using American Society of Transplantation and Cellular Therapy (ASTCT) grading scales.
Steroids used in 1 patient for treatment of neurotoxicity only.
Nineteen of 20 patients had BM disease before treatment (1 patient was MRD-negative in the BM and had EM disease, and at 1-mo reassessments had a continued MRD-negative response in marrow and clearance of EM disease.
Eight patients had EM disease before treatment.