Administered intravenously

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously

Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening; Grade 5: Death related to AE.

Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening; Grade 5: Death related to AE.

Time to neutrophil recovery after KITE-222 infusion & before the start of the conditioning therapy for allo-SCT was calculated as the time from the date of KITE-222 infusion to the first day when neutrophils are 0.5 × 10^9/liter (L), and as the time from the date of KITE-222 infusion to the first day when neutrophils are 1.0 × 10^9/L. Per European Leukemia Net (ELN) 2017 classification, determined by study investigators, CR was defined as bone marrow (BM) blasts <5%; absence of circulating blasts and blasts with Auer rods;absence of extramedullary disease;absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/microliter (μL));platelet count ≥100 × 10^9/L (100000/μL). CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]).

Time to platelet recovery after KITE-222 infusion and before the start of the conditioning therapy for subsequent allo-SCT was calculated as the time from the date of KITE-222 infusion to the first day when platelets are 50 × 10^9/L, and the time from the date of KITE-222 infusion to the first day platelets are 100 × 10^9/L. Per European Leukemia Net (ELN) 2017 classification, determined by study investigators, CR was defined as bone marrow (BM) blasts <5%; absence of circulating blasts and blasts with Auer rods;absence of extramedullary disease;absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/microliter (μL));platelet count ≥100 × 10^9/L (100000/μL). CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]).

CCR rate=Percentage of participants who achieve complete remission (CR) + CR without measurable residual disease (CRMRD-) + CR with incomplete hematologic recovery (CRi) per European Leukemia Net (ELN) 2017 classification, determined by study investigators.CR was defined as bone marrow (BM) blasts <5%; absence of circulating blasts and blasts with Auer rods;absence of extramedullary disease;absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/microliter (μL));platelet count ≥100 × 10^9/L (100000/μL). CRMRD- if studied pretreatment was defined as CR with negativity for genetic marker by real-time quantitative polymerase chain reaction (RT-qPCR) or CR with negativity by multi-color flow cytometry (MFC).CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]).

ORR=percentage of participants who achieved CR+CRMRD- +CRi +morphologic leukemia-free state (MLFS) +partial remission (PR) per the ELN 2017 classification.CR was defined as BM blasts <5%;absence of circulating blasts and blasts with Auer rods;absence of extramedullary disease;ANC ≥1.0 × 10^9/L (1000/ (μL));platelet count ≥100 × 10^9/L (100000/μL).CRMRD- if studied pretreatment = CR with negativity for genetic marker by RT-qPCR or CR with negativity by MFC.CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]). MLFS=BM blasts <5%;absence of blasts with Auer rods;absence of extramedullary disease;no hematologic recovery required.PR=hematologic criteria of CR decrease of BM blast percentage to 5% to 25%;and decrease of pretreatment BM blast percentage by at least 50%.

For participants who experience CR, CRMRD-, or CRi, RFS was defined as the time between their first CR/CRMRD-/CRi to relapse or death due to any cause. CR was defined as BM blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/μL); platelet count ≥100 × 10^9/L (100000/μL). CRMRD- if studied pretreatment was defined as CR with negativity for a genetic marker by RT-qPCR or CR with negativity by MFC. CR with incomplete hematologic recovery was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]).

The allo-SCT rate was defined as the number of participants who received allo-SCT after being treated with KITE-222 divided by the total number of subjects included in the safety analysis set.

EFS was defined as the time from the KITE-222 infusion date to earliest date of disease relapse,progressive disease (PD),refractory disease, or death due to any cause.Relapse: Hematologic : BM blasts ≥ 5%,reappearance of blasts, or development of extramedullary disease;Molecular:If studied before treatment, re-occurrence of MRD assessed by RT-qPCR or MFC, PD:Evidence for increase in BM blast percentage and/or increase of absolute blast counts in blood:> 50% increase in marrow blasts over baseline(minimum 15% point increase required with < 30% blasts at baseline or persistent marrow blast > 70%over 3 months without ≥ 100% improvement in ANC to absolute level (> 0.5 × 10^9/L [500/μL], and/or platelet count to > 50 × 10^9/L [50,000/μL] nontransfused); > 50% increase in peripheral blasts(white blood cells (WBC) x % blasts) to > 25 × 10^9/L (>25,000/μL) (absence of differentiation syndrome);New extramedullary disease.Refractory disease:No CR, CRMRD-, or CRi by Week 6 disease assessment.

OS was defined as the time from KITE-222 infusion to the date of death from any cause.

The mortality was calculated by number of deaths, regardless of cause, within 30 days from the KITE-222 infusion date.

The mortality was calculated by number of deaths, regardless of cause, within 60 days from the KITE-222 infusion date.

Peak was defined as the maximum number of CAR T cells in blood measured after infusion.

AUC0-28 was defined as the area under curve in a plot of number of CAR T cells against scheduled visit from Day 0 to Day 28.

Peak was defined as the maximum levels of Interferon-gamma (IFNg), Interleukin (IL)-12 P40, IL-10, and IL-15 in serum from baseline to Week 4.

Peak was defined as the maximum levels of IL-2 R Alpha and Ferritin in serum from baseline to Week 4.

AUC0-28 was defined as the area under curve in a plot of IFNg, IL-12 P40, IL-10, and IL-15 scheduled visit from Day 0 to Day 28.

AUC0-28 was defined as the area under curve in a plot of IL-2 R Alpha and Ferritin scheduled visit from Day 0 to Day 28.

Participants with r/r AML received lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single infusion of KITE-222 CAR transduced autologous T cells administered IV at the highest dose on Day 0 based on participants body weight.

For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.

An AE was defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a relationship with the study treatment. The definition of an AE includes a worsening of a pre-existing medical condition. Worsening indicates that the pre-existing medical condition has increased in severity, frequency, and/or duration or has an association with a worse outcome. TEAEs were defined as any AEs with onset on or after the date of KITE-222 infusion.

The Safety Analysis Set consisted of all participants treated with any dose of KITE-222.

Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening; Grade 5: Death related to AE.

Participants in the Safety Analysis Set were analyzed.

Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening; Grade 5: Death related to AE.

Participants in the Safety Analysis Set were analyzed.

Time to neutrophil recovery after KITE-222 infusion & before the start of the conditioning therapy for allo-SCT was calculated as the time from the date of KITE-222 infusion to the first day when neutrophils are 0.5 × 10^9/liter (L), and as the time from the date of KITE-222 infusion to the first day when neutrophils are 1.0 × 10^9/L. Per European Leukemia Net (ELN) 2017 classification, determined by study investigators, CR was defined as bone marrow (BM) blasts <5%; absence of circulating blasts and blasts with Auer rods;absence of extramedullary disease;absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/microliter (μL));platelet count ≥100 × 10^9/L (100000/μL). CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]).

Participants in the Safety Analysis Set were analyzed.

Time to platelet recovery after KITE-222 infusion and before the start of the conditioning therapy for subsequent allo-SCT was calculated as the time from the date of KITE-222 infusion to the first day when platelets are 50 × 10^9/L, and the time from the date of KITE-222 infusion to the first day platelets are 100 × 10^9/L. Per European Leukemia Net (ELN) 2017 classification, determined by study investigators, CR was defined as bone marrow (BM) blasts <5%; absence of circulating blasts and blasts with Auer rods;absence of extramedullary disease;absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/microliter (μL));platelet count ≥100 × 10^9/L (100000/μL). CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]).

Participants in the Safety Analysis Set were analyzed.

CCR rate=Percentage of participants who achieve complete remission (CR) + CR without measurable residual disease (CRMRD-) + CR with incomplete hematologic recovery (CRi) per European Leukemia Net (ELN) 2017 classification, determined by study investigators.CR was defined as bone marrow (BM) blasts <5%; absence of circulating blasts and blasts with Auer rods;absence of extramedullary disease;absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/microliter (μL));platelet count ≥100 × 10^9/L (100000/μL). CRMRD- if studied pretreatment was defined as CR with negativity for genetic marker by real-time quantitative polymerase chain reaction (RT-qPCR) or CR with negativity by multi-color flow cytometry (MFC).CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]).

The participants in the modified intent-to-treat (mITT) analysis set were planned to be analyzed. mITT analysis set were to include all participants enrolled & treated with at least 50% optimal dose of KITE-222 including all participants treated in both dose escalation & dose expansion cohort. Study was discontinued at end of the dose escalation without starting the expansion cohort. Participants in Safety Analysis set were reported.

ORR=percentage of participants who achieved CR+CRMRD- +CRi +morphologic leukemia-free state (MLFS) +partial remission (PR) per the ELN 2017 classification.CR was defined as BM blasts <5%;absence of circulating blasts and blasts with Auer rods;absence of extramedullary disease;ANC ≥1.0 × 10^9/L (1000/ (μL));platelet count ≥100 × 10^9/L (100000/μL).CRMRD- if studied pretreatment = CR with negativity for genetic marker by RT-qPCR or CR with negativity by MFC.CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]). MLFS=BM blasts <5%;absence of blasts with Auer rods;absence of extramedullary disease;no hematologic recovery required.PR=hematologic criteria of CR decrease of BM blast percentage to 5% to 25%;and decrease of pretreatment BM blast percentage by at least 50%.

The participants in mITT analysis set were planned to be analyzed. mITT analysis set were to include all participants enrolled & treated with at least 50% optimal dose of KITE-222 including all participants treated in both dose escalation & expansion cohort. Study was discontinued at end of the dose escalation without starting the expansion cohort. Participants in the Safety Analysis Set were reported.

For participants who experience CR, CRMRD-, or CRi, RFS was defined as the time between their first CR/CRMRD-/CRi to relapse or death due to any cause. CR was defined as BM blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/μL); platelet count ≥100 × 10^9/L (100000/μL). CRMRD- if studied pretreatment was defined as CR with negativity for a genetic marker by RT-qPCR or CR with negativity by MFC. CR with incomplete hematologic recovery was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100000/μL]).

The participants in the mITT analysis set were planned to be analyzed. mITT analysis set were to include all participants enrolled and treated with at least 50% of the optimal dose of KITE-222 including all participants treated in both the dose escalation cohort and the expansion cohort. The study was discontinued at the end of the dose escalation without starting the expansion cohort. Since no participants experienced CR, CRMRD-, or CRi, RFS could not be evaluated.

The allo-SCT rate was defined as the number of participants who received allo-SCT after being treated with KITE-222 divided by the total number of subjects included in the safety analysis set.

Participants in the Safety Analysis Set were analyzed.

EFS was defined as the time from the KITE-222 infusion date to earliest date of disease relapse,progressive disease (PD),refractory disease, or death due to any cause.Relapse: Hematologic : BM blasts ≥ 5%,reappearance of blasts, or development of extramedullary disease;Molecular:If studied before treatment, re-occurrence of MRD assessed by RT-qPCR or MFC, PD:Evidence for increase in BM blast percentage and/or increase of absolute blast counts in blood:> 50% increase in marrow blasts over baseline(minimum 15% point increase required with < 30% blasts at baseline or persistent marrow blast > 70%over 3 months without ≥ 100% improvement in ANC to absolute level (> 0.5 × 10^9/L [500/μL], and/or platelet count to > 50 × 10^9/L [50,000/μL] nontransfused); > 50% increase in peripheral blasts(white blood cells (WBC) x % blasts) to > 25 × 10^9/L (>25,000/μL) (absence of differentiation syndrome);New extramedullary disease.Refractory disease:No CR, CRMRD-, or CRi by Week 6 disease assessment.

The participants in the mITT analysis set were planned to be analyzed. mITT analysis set were to include all participants enrolled and treated with at least 50% of the optimal dose of KITE-222 including all participants treated in both the dose escalation cohort and the expansion cohort. The study was discontinued at the end of the dose escalation without starting the expansion cohort. Participants in the Safety Analysis Set were reported.

OS was defined as the time from KITE-222 infusion to the date of death from any cause.

Participants in the Safety Analysis Set were analyzed.

The mortality was calculated by number of deaths, regardless of cause, within 30 days from the KITE-222 infusion date.

Participants in the Safety Analysis Set were analyzed.

The mortality was calculated by number of deaths, regardless of cause, within 60 days from the KITE-222 infusion date.

Participants in the Safety Analysis Set were analyzed.

Peak was defined as the maximum number of CAR T cells in blood measured after infusion.

Participants in the Safety Analysis Set were analyzed.

AUC0-28 was defined as the area under curve in a plot of number of CAR T cells against scheduled visit from Day 0 to Day 28.

Participants in the Safety Analysis Set were analyzed.

Peak was defined as the maximum levels of Interferon-gamma (IFNg), Interleukin (IL)-12 P40, IL-10, and IL-15 in serum from baseline to Week 4.

Participants in the Safety Analysis Set were analyzed.

Peak was defined as the maximum levels of IL-2 R Alpha and Ferritin in serum from baseline to Week 4.

Participants in the Safety Analysis Set were analyzed.

AUC0-28 was defined as the area under curve in a plot of IFNg, IL-12 P40, IL-10, and IL-15 scheduled visit from Day 0 to Day 28.

Participants in the Safety Analysis Set were analyzed.

AUC0-28 was defined as the area under curve in a plot of IL-2 R Alpha and Ferritin scheduled visit from Day 0 to Day 28.

Participants in the Safety Analysis Set were analyzed.

Participants in the Safety Analysis Set were analyzed.

Participants with r/r AML received lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single infusion of KITE-222 CAR transduced autologous T cells administered IV at a higher dose on Day 0 based on participants body weight.

Participants with r/r AML received lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single infusion of KITE-222 CAR transduced autologous T cells administered IV at the highest dose on Day 0 based on participants body weight.