Fig. 2. CONSORT diagram and patient CAR T cell dosing.
a,b, CONSORT flow diagram (a) and the total AUTO3 dose and schedule (single versus split dose) for each patient treated with AUTO3 (b). Of the 20 patients who underwent leukapheresis, 15 received AUTO3 because two patients died, two discontinued due to progressive disease before the start of any study treatment and one AUTO3 final product was not released by quality control (†classified as manufacturing failure). CAR T cells were infused as a single dose on d 0 for 12 of the 15 patients. Three patients received a dose that was split. For one patient the dose was split between d 0 and d 3. For two patients the dose was split between d 0 and d 5. Target doses of 1 × 106, 3 × 106 and 5 × 106 cells per kg were explored. There were three outliers: patient 001 received a total of 0.3 × 106 cells per kg because after the first dose a serious adverse event (encephalopathy) occurred and prevented him from receiving the second dose of 0.7 × 106 cells per kg; patient 003 was enrolled in the 1 × 106 cells per kg cohort and 2 × 106 cells per kg were manufactured, but the 3 × 106 cells per kg cohort was opened at the time of dosing and he therefore received the full dose available (2 × 106 cells per kg); and patient 022 had a poor leukapheresis product (>70% blasts), and Autolus was able to manufacture 4.3 × 106 cells per kg. F, female; M, male.