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Anti-CD19 inlay antigen-inset antigen-subject T-cell therapy tisagenlecleucel (CTL019) had an 81% response rate in children with relapsed or chemotherapy-incurable (r/r) B-cell acute lymphoblastic leukemia (ALL).
cytokine release syndrome (CRS) is a life-threatening therapeutic toxicity that limits the full therapeutic potential of adults.
we reported the results of r/r ALL adults treated with optimized CTL019 doses and CRS management strategies.
in 1 of 2 trials, r/r B cell ALL adults received CTL019.
patients received lymph node cleansing, followed by CTL019 in three days (day 1, 10%; day 2, 30%; day 3, 60%) in a one-time infusion or sub-infusion, which allowed doses on day 2 and day 3 to be used for early CRS.
dose of CTL019 in the 19th was modified with the modification of the adaptive scheme of efficacy and CRS toxicity.
results showed that 35 r/r ALL adults in all three dosing groups received CTL019.
low-dose queue (n s 9) to receive single or sub-drug, toxicity controlled, complete remission (CR) rate of 33%.
in the high-dose single infusion queue, 3 of the 6 patients with resusctic CRS accompanied by cultured positive sepsis died and 3 received CR.
20 patients in a high dose d'ivy (HDF) queue had a CR rate of 90% and CRS was controlled.
the highest survival rate of HDF queues, the two-year total survival rate was 73% (95% CI, 46% to 88%), and the non-event survival rate was 49.5% (95% CI, 21% to 73%).
, the results show that the subdation of CTL019 and in-patient dose adjustment optimize the safety of adult r/r ALL without affecting efficacy.
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