Characteristics of adverse events following cilta-cel
| Toxicities . | Patients (N = 5) . |
|---|---|
| Initial toxicity | |
| CRS, n (%) | 5 (100%) |
| Peak grade,∗ median (range) | 1 (1-2) |
| Time to onset, days (range) | 5 (5-6) |
| Duration, d (range) | 4 (1-8) |
| ICANS, n (%) | 1 (20) |
| Peak grade† | 4 |
| Time to onset, d | 5 |
| Duration, d | 47 |
| Therapies for CRS/ICANS, n (%) | |
| Tocilizumab | 5 (100) |
| Dexamethasone | 5 (100) |
| Anakinra | 2 (40) |
| IEC-HS, n (%) | 2 (40) |
| Overall response rate, n (%) | 5 (100) |
| VGPR | 2 (40) |
| CR/sCR | 3 (60) |
| Disposition, n | |
| Discharged to skilled nursing facility | 2 |
| Progression | 2 |
| Death from progression | 2 |
| Delayed parkinsonism | |
| Onset from CAR T-cell therapy, d (range) | 26 (9-36) |
| Symptoms, n (%) | |
| ICE score <10 at onset | 3 (60) |
| Word finding difficulty | 5 (100) |
| Masked facies | 5 (100) |
| Personality changes (flat affect, anhedonia, avolition) | 5 (100) |
| Anosmia | 3 (60) |
| Resting tremor | 3 (60) |
| Rigidity | 2 (40) |
| Impaired swallowing | 2 (40) |
| Micrographia | 2 (40) |
| Bradykinesia | 2 (40) |
| Shuffling gait | 1 (20) |
| Inflammatory markers during episode | |
| CRP at onset, median (range) | <3 (<3 to 53) |
| ALC (109/L) at onset, median (range) | 1.84 (0.03-2.14) |
| Peak ferritin, median (range) | 429 (154-4167) |
| Peak LDH, median (range) | 428 (252-705) |
| Elevated Soluble IL-2R (pg/mL), n (%)‡ | 2 (100) |
| Neurologic workup | |
| Abnormal MRI findings | 1 (20) |
| Seizure activity on EEG | 0 (0) |
| CSF findings | |
| CSF WBC count (/μL), median (range) | 42 (2-140) |
| CSF pleocytosis (>5 WBC/μL), n (%) | 4 (80) |
| CSF lymphocyte %, median (range) | 90 (89-95) |
| Resolution of MNT | |
| Days to clinical improvement, median (range)§ | 7 (3-39) |
| Days to complete resolution, median (range)§ | 34 (13-40) |
| Toxicities . | Patients (N = 5) . |
|---|---|
| Initial toxicity | |
| CRS, n (%) | 5 (100%) |
| Peak grade,∗ median (range) | 1 (1-2) |
| Time to onset, days (range) | 5 (5-6) |
| Duration, d (range) | 4 (1-8) |
| ICANS, n (%) | 1 (20) |
| Peak grade† | 4 |
| Time to onset, d | 5 |
| Duration, d | 47 |
| Therapies for CRS/ICANS, n (%) | |
| Tocilizumab | 5 (100) |
| Dexamethasone | 5 (100) |
| Anakinra | 2 (40) |
| IEC-HS, n (%) | 2 (40) |
| Overall response rate, n (%) | 5 (100) |
| VGPR | 2 (40) |
| CR/sCR | 3 (60) |
| Disposition, n | |
| Discharged to skilled nursing facility | 2 |
| Progression | 2 |
| Death from progression | 2 |
| Delayed parkinsonism | |
| Onset from CAR T-cell therapy, d (range) | 26 (9-36) |
| Symptoms, n (%) | |
| ICE score <10 at onset | 3 (60) |
| Word finding difficulty | 5 (100) |
| Masked facies | 5 (100) |
| Personality changes (flat affect, anhedonia, avolition) | 5 (100) |
| Anosmia | 3 (60) |
| Resting tremor | 3 (60) |
| Rigidity | 2 (40) |
| Impaired swallowing | 2 (40) |
| Micrographia | 2 (40) |
| Bradykinesia | 2 (40) |
| Shuffling gait | 1 (20) |
| Inflammatory markers during episode | |
| CRP at onset, median (range) | <3 (<3 to 53) |
| ALC (109/L) at onset, median (range) | 1.84 (0.03-2.14) |
| Peak ferritin, median (range) | 429 (154-4167) |
| Peak LDH, median (range) | 428 (252-705) |
| Elevated Soluble IL-2R (pg/mL), n (%)‡ | 2 (100) |
| Neurologic workup | |
| Abnormal MRI findings | 1 (20) |
| Seizure activity on EEG | 0 (0) |
| CSF findings | |
| CSF WBC count (/μL), median (range) | 42 (2-140) |
| CSF pleocytosis (>5 WBC/μL), n (%) | 4 (80) |
| CSF lymphocyte %, median (range) | 90 (89-95) |
| Resolution of MNT | |
| Days to clinical improvement, median (range)§ | 7 (3-39) |
| Days to complete resolution, median (range)§ | 34 (13-40) |
ALC, absolute lymphocyte count; CRS, cytokine release syndrome; CR, complete response; CRP, C-reactive protein; EEG, electroencephalogram; ICANS, immune effector cell–associated neurotoxicity syndrome; ICE score, immune effector cell–associated encephalopathy score; IL-2R, interleukin-2R; LDH, lactate dehydrogenase; MRI, magnetic resonance imaging; MNT, movement and neurologic toxicities; sCR, stringent complete response; VGPR, very good partial response; WBC, white blood cell.
CRS grading per American Society for Transplantation and Cellular Therapy criteria.
ICANS grading per American Society for Transplantation and Cellular Therapy criteria.
Soluble IL-2R (range, 603.7-10200.5) pg/mL.
All 5 patients had clinical improvement of MNT symptoms; 4 had complete resolution.