Table 2 Immune effector-mediated toxicities of special interest.
Part A - Dose Escalation | Part B- Dose Expansion | RP2D (Parts A + B) | Total | |||
|---|---|---|---|---|---|---|
DL1 | DL2 | DL3 | DL2 | DL2 | ||
N=7 | N=24 | N=11 | N=23 | N=47 | N=65 | |
CRS | ||||||
Any grade | 5 (71%) | 20 (83%) | 9 (82%) | 19 (83%) | 39 (83%) | 53 (82%) |
Grade 1 | 2 (29%) | 17 (71%) | 9 (82%) | 14 (61%) | 31 (66%) | 42 (65%) |
Grade 2 | 3 (43%) | 2 (13%) | 0 (0%) | 4 (17%) | 7 (15%) | 10 (15%) |
Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (4%) | 1 (2%) | 1 (2%) |
Grade 5 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Median days from infusion to onset of CRS (range) | 4 (1-8) | 4 (2-6) | 4 (2-6) | 4 (2-6) | 4 (2-6) | 4 (1-8) |
Median duration of CRS in days (range) | 2 (2-9) | 3 (1-6) | 4 (2-8) | 5 (2-7) | 4 (1-7) | 4 (1-9) |
Treatment of CRS | ||||||
Tocilizumab | 5 (71%) | 18 (75%) | 7 (64%) | 18 (78%) | 36 (77%) | 48 (74%) |
Dexamethasone | 3 (43%) | 12 (50%) | 4 (36%) | 12 (52%) | 24 (51%) | 31 (48%) |
Anakinra | 3 (43%) | 3 (13%) | 1 (9%) | 3 (13%) | 6 (13%) | 10 (15%) |
Neurotoxicity | ||||||
Any grade | 1 (14%) | 2 (8%) | 1 (9%) | 1 (4%) | 3 (6%) | 5 (8%) |
Grade 1 | 1 (14%) | 2 (8%) | 1 (9%) | 0 (0%) | 2 (4%) | 4 (6%) |
Grade 2 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (4%) | 1 (2%) | 1 (2%) |
Grade 5 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Median days from infusion to onset of neurotoxicity (range) | 8 (8–8) | 7 (5–9) | 5 (5–5) | 5 (5–5) | 5 (5–9) | 5 (5–9) |
Median duration of neurotoxicity in days (range) | 2 (2–2) | 3 (3–3) | 2 (2–2) | 11 (1–12) | 3 (1–12) | 3 (1–12) |
Corticosteroids for treatment of neurotoxicity | 1 (14%) | 0 (0%) | 0 (0%) | 2 (9%) | 2 (4%) | 3 (5%) |
