Figure 1.
Flow diagram. The reasons for patients not enrolling in the study after screening included 2 patients withdrawing voluntarily, 4 patients not meeting the inclusion criteria (<5% blasts in the bone marrow at the screening), and 19 patients meeting the exclusion criteria (including hepatitis B infection, hepatitis C infection, Epstein-Barr virus infection, cytomegalovirus infection, or uncontrolled infection in 11 patients; physician decision in 4 patients due to rapid disease progression; ineligible for apheresis procedure in 3 patients, and central nervous system leukemia in 1 patient). All patients who completed screening and whose apheresis product was received by the manufacturing facility were enrolled in the study. Reasons for treatment discontinuation before lymphodepletion included: uncontrolled infection (n = 6), voluntary withdrawal (n = 3), physician decision (n = 2; 1 patient remitted after bridging chemotherapy, and 1 patient was diagnosed as mixed-phenotype acute leukemia), and ineligibility (n = 1). After lymphodepletion, 7 patients did not proceed to Inati-cel infusion due to physician decision (n = 2; 1 patient accompanied with teratoma and 1 patient remitted), uncontrolled infection (n = 2), and rapid disease progression (n = 3).

Flow diagram. The reasons for patients not enrolling in the study after screening included 2 patients withdrawing voluntarily, 4 patients not meeting the inclusion criteria (<5% blasts in the bone marrow at the screening), and 19 patients meeting the exclusion criteria (including hepatitis B infection, hepatitis C infection, Epstein-Barr virus infection, cytomegalovirus infection, or uncontrolled infection in 11 patients; physician decision in 4 patients due to rapid disease progression; ineligible for apheresis procedure in 3 patients, and central nervous system leukemia in 1 patient). All patients who completed screening and whose apheresis product was received by the manufacturing facility were enrolled in the study. Reasons for treatment discontinuation before lymphodepletion included: uncontrolled infection (n = 6), voluntary withdrawal (n = 3), physician decision (n = 2; 1 patient remitted after bridging chemotherapy, and 1 patient was diagnosed as mixed-phenotype acute leukemia), and ineligibility (n = 1). After lymphodepletion, 7 patients did not proceed to Inati-cel infusion due to physician decision (n = 2; 1 patient accompanied with teratoma and 1 patient remitted), uncontrolled infection (n = 2), and rapid disease progression (n = 3).

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