Table 1.
Patient demographics and details of toxicities including CRS and ICANS.
| Pt | Age (years) | Gender | Primary Diagnosis | Disease Burden | CART Product | Max. CRS Grade |
Max. ICANS Grade |
Symptoms | CRS Onset from Infusion & Treatment | ICANS Onset from Infusion & Treatment | Baseline CAPD | First Increase CAPD prior to ICANS | Max.CAPD prior to ICANS | Max. CAPD | Min. ICE |
CTCAE V5 Neurotoxicity |
ICANS Duration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 23 | M | Pre-B ALL, BM relapse |
PLD PB: WBC 13.5 K/μl, Blasts 14% |
Tisagen-lecleucel | 3 | 2 | AMS, dysgraphia | 7 days; tocilizumab × 4 doses | 9 days; dexamethasone |
0 | 48 h | 4 | N/A | 3 | Grade 2: Moderate disorientation and dysphasia |
< 24 h |
| 2 | 8 | F | Pre-B ALL, BM and CNS relapse |
PLD BM: Blasts 30%, MRD 20% |
Tisagen-lecleucel | 3 | 3 | AMS, aphasia, dysgraphia | 6 days | 7 days; dexamethasone |
1 | 72 h | 10 | 14 | – | Grade 3: Severe disorientation and dysphasia |
96 h |
| 3 | 18 | F | Primary Mediastinal Large B-cell Lymphoma | PLP PETCT: Disease progression, Deauville score 5 |
Axicabta-gene Ciloleucel | 1 | 3 | AMS, dysgraphia | 6 days; tocilizumab × 1 dose | 6 days; dexamethasone | 1 | 0 h | 0 | 14 | 1 | Grade 3: Severe disorientation and dysphasia |
24 h |
| 4 | 9 | M | Pre-B ALL, BM and CNS relapse |
PLD PB: WBC 4.2 K/μl, Blasts 1% PLP BM: MRD 96% |
Tisagen-lecleucel | 4 | 3 | GTC Seizure, AMS, dysgraphia | 2 days; tocilizumab × 3 doses, siltuximab | 12 days; dexamethasone | 1 | 48 h | 4 | 5 | – | Grade 2: Seizure |
< 24 h |
| 5 | 22 | F | Pre-B ALL, breast relapse | PLP BM: Blasts 3%, MRD negative |
Tisagen-lecleucel | 1 | 3 | AMS, aphasia | 3 days; tocilizumab × 1 dose | 5 days | 0 | 0 h | 0 | 7 | 0 | Grade 3: Severe somnolence |
< 24 h |
| 6 | 25 | F | Pre-B ALL, BM and CNS relapse |
PLD PB: WBC 9.4 K/μl, Blasts 37% |
Tisagen-lecleucel | 3 | 3 | AMS, dysgraphia | 7 days; tocilizumab × 4 doses | 8 days; dexamethasone | 0 | 24 h | 10 | 16 | 1 | Grade 3: Severe disorientation and dysphasia |
168 h |
Baseline CAPD assigned is the mean of the first two CAPD scores after admission prior to cell infusion. CRS and ICANS grades correspond to current ASTCT consensus grading guidelines. Resolution of ICANS corresponded to return of CAPD score to patient’s baseline and resolution of symptoms as documented by clinical assessments. Patient 1 had serial ICE scores and did not have CAPD scores available around the time of ICANS diagnosis.
ALL, acute lymphoblastic leukemia; PB, peripheral blood; BM, bone marrow; CNS, central nervous system; PLP, pre-leukapheresis; PLD, pre-lymphodepletion; WBC, white blood cell; AMS, altered mental status; GTC, generalized tonic-clonic; CTCAE, Common Terminology Criteria for Adverse Events.