Figure 1.
Study oversight and consort diagram. (A) Treatment schema of the entire clinical trial. (B-C) Schema of CAR T1 to CAR T4. Before each cycle of CD19 CAR T cells, the FC regimen (fludarabine 30 mg/m2 daily and cyclophosphamide 300 mg/m2 daily) for lymphodepletion was given on days −5, −4, and −3. CD19 CAR T cells were infused at a total dose of 5 × 106 cells per kg on day 1 to day 3 of CAR T1 and day 1 of CAR T2 to T4, whereas CD19+ FTCs were infused 2 hours after the infusion of CD19 CAR T cells on day 1 and at the same dose alone on day 8 of CAR T2 to T4. Based on the preclinical data, the stimulation of CD19 CAR T cells via CD19+ FTCs at a ratio of 1:1 was seen to be the optimum ratio. Therefore, 5 × 106/kg of CD19+ FTCs was set as the starting dosage in our study. Moreover, considering the limited number of T cells harvested from a single apheresis from the patientsand the cost-effectiveness, we evaluated the minimum effective doses, ie, CD19+ FTCs (3.25 × 106/kg and 2 × 106/kg), to be used in our study. Therefore, CD19+ FTCs were administered at 3 different doses (5 × 106/kg, 3.25 × 106/kg, or 2 × 106/kg) to assess an optimal biologic CD19+ FTC dose. (D) Consort diagram describing the patient population. A total of 15 patients had enrolled in our phase I clinical trial. On 3 November 2019, we modified our original protocol owing to the observation of CNS leukemia in 1 patient (patient 4). Two cycles of systemic therapy after induction therapy and a total of 11 triple intrathecal injections (methotrexate, cytarabine, and dexamethasone) were included for the prevention of CNS leukemia. Three patients were already initiated on CAR T-cell therapy before the amendment, and therefore they were absent from the systemic chemotherapy. One patient (patient 7) withdrew because of fungal pneumonia that occurred after 1 cycle of systemic chemotherapy when he had a hematological CR. Patient 15 withdrew because of an isolated CNS relapse after 1 cycle of systemic chemotherapy. She achieved CR2 after multiple intrathecal therapies and underwent HSCT. Unfortunately, she died of a second relapse in the CNS.

Study oversight and consort diagram. (A) Treatment schema of the entire clinical trial. (B-C) Schema of CAR T1 to CAR T4. Before each cycle of CD19 CAR T cells, the FC regimen (fludarabine 30 mg/m2 daily and cyclophosphamide 300 mg/m2 daily) for lymphodepletion was given on days −5, −4, and −3. CD19 CAR T cells were infused at a total dose of 5 × 106 cells per kg on day 1 to day 3 of CAR T1 and day 1 of CAR T2 to T4, whereas CD19+ FTCs were infused 2 hours after the infusion of CD19 CAR T cells on day 1 and at the same dose alone on day 8 of CAR T2 to T4. Based on the preclinical data, the stimulation of CD19 CAR T cells via CD19+ FTCs at a ratio of 1:1 was seen to be the optimum ratio. Therefore, 5 × 106/kg of CD19+ FTCs was set as the starting dosage in our study. Moreover, considering the limited number of T cells harvested from a single apheresis from the patientsand the cost-effectiveness, we evaluated the minimum effective doses, ie, CD19+ FTCs (3.25 × 106/kg and 2 × 106/kg), to be used in our study. Therefore, CD19+ FTCs were administered at 3 different doses (5 × 106/kg, 3.25 × 106/kg, or 2 × 106/kg) to assess an optimal biologic CD19+ FTC dose. (D) Consort diagram describing the patient population. A total of 15 patients had enrolled in our phase I clinical trial. On 3 November 2019, we modified our original protocol owing to the observation of CNS leukemia in 1 patient (patient 4). Two cycles of systemic therapy after induction therapy and a total of 11 triple intrathecal injections (methotrexate, cytarabine, and dexamethasone) were included for the prevention of CNS leukemia. Three patients were already initiated on CAR T-cell therapy before the amendment, and therefore they were absent from the systemic chemotherapy. One patient (patient 7) withdrew because of fungal pneumonia that occurred after 1 cycle of systemic chemotherapy when he had a hematological CR. Patient 15 withdrew because of an isolated CNS relapse after 1 cycle of systemic chemotherapy. She achieved CR2 after multiple intrathecal therapies and underwent HSCT. Unfortunately, she died of a second relapse in the CNS.

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