Trial Outcomes & Findings for Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (NCT NCT04789408)

Last Updated: 2025-07-11

Results Overview

DLTs defined as KITE-222-related events with an onset within the first 28 days after the KITE-222 infusion:Grade(GR) 5 event,GR 4 cytokine release syndrome(CRS) or GR 3 CRS not improving to ≤ GR 2 by 72 hours,≥GR 3 cardiac and/or pulmonary event(Exceptions:related to CRS and improve to ≤GR 2 by 72 hours, managed by noninvasive care \& resolves to baseline by Day28),GR 4 immune-effector cell-associated neurotoxicity syndrome(ICANS) or other GR 4 adverse events(AEs)associated to neurologic events,GR 3 ICANS(Exceptions: GR 3 ICANS based only on immune-effector cell-associated encephalopathy(ICE) score and/or depressed level of consciousness that improves to ≤GR 2 by 72 hours),≥GR 3 infusion or immediate hypersensitivity reaction,Ongoing GR 4 neutropenia or thrombocytopenia(not due to leukemia persistence)by Day 42 to who have not had conditioning regimen for allo-stem cell transplant,other KITE-222 related GR 3 non-hematologic AEs lasting \>7 days,KITE-222-related GR 4 non-hematologic AEs.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2025-07-11

Participant Flow

Participants were enrolled at study sites in France and the United States.

17 participants were screened. Dose expansion cohort was not initiated due to early termination of the study. There were no participants enrolled in the expansion cohort.

Participant milestones

Participant milestones
Measure	Cohort 1: KITE-222 (Low Dose) Participants with relapsed or refractory (r/r) acute myeloid leukemia (AML) received lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single infusion of KITE-222 chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) 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.	Cohort 3: KITE-222 (Highest Dose) 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.
Overall Study STARTED	5	3	7
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	5	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: KITE-222 (Low Dose) Participants with relapsed or refractory (r/r) acute myeloid leukemia (AML) received lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single infusion of KITE-222 chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) 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.	Cohort 3: KITE-222 (Highest Dose) 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.
Overall Study Death	4	3	6
Overall Study Did not meet eligibility criteria	1	0	0
Overall Study Participant withdrawal of consent from further follow-up	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.	Total~(N=12) n=12 Participants
Age, Continuous	60 years STANDARD_DEVIATION 13.9 • n=3 Participants	54 years STANDARD_DEVIATION 11.4 • n=3 Participants	56 years STANDARD_DEVIATION 13.3 • n=6 Participants	56 years STANDARD_DEVIATION 12.0 • n=12 Participants
Sex: Female, Male Female	1 Participants n=3 Participants	1 Participants n=3 Participants	3 Participants n=6 Participants	5 Participants n=12 Participants
Sex: Female, Male Male	2 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=6 Participants	7 Participants n=12 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=3 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	0 Participants n=3 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	0 Participants n=5 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	1 Participants n=11 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=3 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	3 Participants n=3 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	5 Participants n=5 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	10 Participants n=11 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	0 Participants n=3 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	0 Participants n=5 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.	0 Participants n=11 Participants • For Ethnicity, data was not collected for 1 participant in the Cohort 3: KITE-222 (Highest Dose) group.
Race/Ethnicity, Customized Race · White	2 Participants n=3 Participants	2 Participants n=3 Participants	4 Participants n=6 Participants	8 Participants n=12 Participants
Race/Ethnicity, Customized Race · Other or More Than One Race	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=6 Participants	3 Participants n=12 Participants
Race/Ethnicity, Customized Race · Black or African American	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	1 Participants n=12 Participants
Region of Enrollment United States	3 Participants n=3 Participants	3 Participants n=3 Participants	4 Participants n=6 Participants	10 Participants n=12 Participants
Region of Enrollment France	0 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=6 Participants	2 Participants n=12 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: DLT-evaluable set consisted of participants treated in each dose-escalation cohort who: * Received the target dose and were followed for at least 28 days after infusion of KITE-222; or * Received a dose of KITE-222 that was lower than the target for that cohort and experienced a DLT during the 28-day post infusion period

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=5 Participants 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.
Percentage of Participants Who Experienced Dose Limiting Toxicities (DLTs)	0 percentage of participants	0 percentage of participants	20 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.2 months

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

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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)	100 percentage of participants	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Bilirubin	0 percentage of participants	0 percentage of participants	17 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Direct Bilirubin	0 percentage of participants	33 percentage of participants	33 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Glucose	33 percentage of participants	100 percentage of participants	17 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Alanine Aminotransferase	0 percentage of participants	0 percentage of participants	17 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Alkaline Phosphatase	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Aspartate Aminotransferase	0 percentage of participants	33 percentage of participants	17 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Calcium	0 percentage of participants	33 percentage of participants	33 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Potassium	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Creatinine	0 percentage of participants	0 percentage of participants	33 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Magnesium	0 percentage of participants	0 percentage of participants	17 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Sodium	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Chemistry: Urate	0 percentage of participants	0 percentage of participants	33 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Hematology: Lymphocytes	0 percentage of participants	0 percentage of participants	17 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Hematology: Platelets	33 percentage of participants	0 percentage of participants	50 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Chemistry: Glucose	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Chemistry: Albumin	0 percentage of participants	0 percentage of participants	33 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Chemistry: Phosphate	0 percentage of participants	67 percentage of participants	67 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Chemistry: Calcium	33 percentage of participants	0 percentage of participants	33 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Chemistry: Potassium	33 percentage of participants	0 percentage of participants	50 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Chemistry: Magnesium	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Chemistry: Sodium	0 percentage of participants	0 percentage of participants	17 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Hematology: Lymphocytes	100 percentage of participants	67 percentage of participants	83 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Hematology: Hemoglobin	67 percentage of participants	33 percentage of participants	50 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Hematology: Leukocytes	33 percentage of participants	67 percentage of participants	67 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Hematology: Neutrophils	0 percentage of participants	33 percentage of participants	17 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: 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 \[100000/μL\]).

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Time to Neutrophil Recovery	NA months None of the participants met the criteria for CR, or Cri, thus the time to neutrophil /platelet recovery could not be calculated.	NA months None of the participants met the criteria for CR, or Cri, thus the time to neutrophil /platelet recovery could not be calculated.	NA months None of the participants met the criteria for CR, or Cri, thus the time to neutrophil /platelet recovery could not be calculated.

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: 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 \[100000/μL\]).

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Time to Platelet Recovery	NA months None of the participants met the criteria for CR, or Cri, thus the time to neutrophil /platelet recovery could not be calculated.	NA months None of the participants met the criteria for CR, or Cri, thus the time to neutrophil /platelet recovery could not be calculated.	NA months None of the participants met the criteria for CR, or Cri, thus the time to neutrophil /platelet recovery could not be calculated.

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: 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.

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 \[100000/μL\]).

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Composite Complete Remission (CCR) Rate	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: 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.

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%.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Overall Remission Rate (ORR)	0 percentage of participants	0 percentage of participants	16.67 percentage of participants

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: 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.

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 \[100000/μL\]).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: Participants in the Safety Analysis Set were analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Allogeneic Stem Cell Transplant (Allo-SCT) Rate	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 12.3 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Event-free Survival (EFS)	26 days Interval 15.0 to 28.0	23 days Interval 9.0 to 42.0	21.5 days Interval 14.0 to 48.0

SECONDARY outcome

Timeframe: Up to 12.3 months

Population: Participants in the Safety Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Overall Survival (OS)	2.6 months Interval 1.1 to 7.5	4.7 months Interval 2.9 to 12.3	2.6 months Interval 0.9 to 6.3

SECONDARY outcome

Timeframe: Up to 30 days

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
All-cause Mortality Within 30 Days of KITE-222 Infusion	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 60 days

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
All-cause Mortality Within 60 Days of KITE-222 Infusion	1 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline (Day 0), post dose on Days 3, 7,10, Weeks 2, 3, 4, and 6

Population: Participants in the Safety Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Pharmacokinetics (PK) Parameter: Peak Level of KITE-222 CAR T Cells in Blood	2.18 cells per microliter (cells/µL) Interval 0.0 to 9.91	0.08 cells per microliter (cells/µL) Interval 0.0 to 6.05	3.88 cells per microliter (cells/µL) Interval 0.9 to 79.17

SECONDARY outcome

Timeframe: Baseline (Day 0), post dose on Days 3, 7, 10, Weeks 2, 3, and 4

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
PK Parameter: Area Under the Curve for the Blood Level of KITE-222 CAR T Cells From Day 0 to Day 28 (AUC0-28)	25.09 cells/µL*days Interval 0.0 to 76.9	0.47 cells/µL*days Interval 0.0 to 58.26	26.66 cells/µL*days Interval 8.96 to 340.96

SECONDARY outcome

Timeframe: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Pharmacodynamics (PD) Parameter: Peak Serum Levels of Interferon-gamma (IFNg), Interleukin (IL)-12 P40, IL-10, and IL-15 IFNg	89.80 picograms per milliliter (pg/mL) Interval 20.2 to 463.0	150.10 picograms per milliliter (pg/mL) Interval 25.2 to 557.8	1876.00 picograms per milliliter (pg/mL) Interval 177.6 to 1876.0
Pharmacodynamics (PD) Parameter: Peak Serum Levels of Interferon-gamma (IFNg), Interleukin (IL)-12 P40, IL-10, and IL-15 IL-12 P40	22.30 picograms per milliliter (pg/mL) Interval 21.9 to 339.7	195.80 picograms per milliliter (pg/mL) Interval 21.5 to 312.8	27.60 picograms per milliliter (pg/mL) Interval 5.7 to 73.0
Pharmacodynamics (PD) Parameter: Peak Serum Levels of Interferon-gamma (IFNg), Interleukin (IL)-12 P40, IL-10, and IL-15 IL-10	9.60 picograms per milliliter (pg/mL) Interval 2.2 to 71.5	16.50 picograms per milliliter (pg/mL) Interval 12.2 to 34.3	145.45 picograms per milliliter (pg/mL) Interval 12.3 to 466.0
Pharmacodynamics (PD) Parameter: Peak Serum Levels of Interferon-gamma (IFNg), Interleukin (IL)-12 P40, IL-10, and IL-15 IL-15	30.30 picograms per milliliter (pg/mL) Interval 28.3 to 46.2	51.00 picograms per milliliter (pg/mL) Interval 27.0 to 62.7	99.65 picograms per milliliter (pg/mL) Interval 24.7 to 185.3

SECONDARY outcome

Timeframe: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
PD Parameter: Peak Serum Levels of IL-2 R Alpha and Ferritin IL-2 R Alpha	5.15 nanograms per milliliter (ng/mL) Interval 2.92 to 6.71	2.90 nanograms per milliliter (ng/mL) Interval 2.04 to 6.61	21.32 nanograms per milliliter (ng/mL) Interval 7.07 to 52.67
PD Parameter: Peak Serum Levels of IL-2 R Alpha and Ferritin Ferritin	16200 nanograms per milliliter (ng/mL) Interval 4716.45 to 31600.0	11200 nanograms per milliliter (ng/mL) Interval 4539.18 to 17300.0	27900 nanograms per milliliter (ng/mL) Interval 5825.07 to 31600.0

SECONDARY outcome

Timeframe: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
PD Parameter: AUC0-28 for the Serum Levels IFNg, IL-12 P40, IL-10, and IL-15 in Serum IFNg	1051.60 pg/mL*days Interval 266.55 to 5288.2	451.50 pg/mL*days Interval 221.55 to 5163.7	7317.53 pg/mL*days Interval 1161.45 to 20400.0
PD Parameter: AUC0-28 for the Serum Levels IFNg, IL-12 P40, IL-10, and IL-15 in Serum IL-12 P40	575.20 pg/mL*days Interval 295.2 to 8040.25	1534.05 pg/mL*days Interval 433.35 to 5362.45	391.60 pg/mL*days Interval 216.85 to 1175.3
PD Parameter: AUC0-28 for the Serum Levels IFNg, IL-12 P40, IL-10, and IL-15 in Serum IL-10	148.15 pg/mL*days Interval 25.35 to 426.3	108.95 pg/mL*days Interval 59.7 to 401.4	809.58 pg/mL*days Interval 115.25 to 3078.85
PD Parameter: AUC0-28 for the Serum Levels IFNg, IL-12 P40, IL-10, and IL-15 in Serum IL-15	415.15 pg/mL*days Interval 382.25 to 1033.7	668.60 pg/mL*days Interval 181.9 to 1361.6	1021.05 pg/mL*days Interval 540.55 to 2322.0

SECONDARY outcome

Timeframe: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
PD Parameter: AUC0-28 for the Serum Levels of IL-2 R Alpha and Ferritin Ferritin	208000 ng /mL*days Interval 119000.0 to 353000.0	119000 ng /mL*days Interval 86000.0 to 247000.0	282000 ng /mL*days Interval 82900.0 to 593000.0
PD Parameter: AUC0-28 for the Serum Levels of IL-2 R Alpha and Ferritin IL-2 R Alpha	114.36 ng /mL*days Interval 87.0 to 155.16	56.61 ng /mL*days Interval 43.65 to 145.54	302.03 ng /mL*days Interval 149.22 to 677.94

SECONDARY outcome

Timeframe: Up to 3.2 months

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Cohort 1: KITE-222 (Low Dose) n=3 Participants 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 Participants 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.	Cohort 3: KITE-222 (Highest Dose) n=6 Participants 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.
Percentage of Participants Who Develop Anti-KITE-222 CAR Antibodies	0 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

Cohort 1: KITE-222 (Low Dose)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 4 deaths

Cohort 2: KITE-222 (Higher Dose)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 3: KITE-222 (Highest Dose)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Information

Kite, A Gilead Company

Phone: 844-454-5483 (1-844-454-KITE)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1: KITE-222 (Low Dose) n=3 participants at risk 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 low dose on Day 0 based on participants body weight.	Cohort 2: KITE-222 (Higher Dose) n=3 participants at risk 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.	Cohort 3: KITE-222 (Highest Dose) n=6 participants at risk 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.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	16.7% 1/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Cardiac disorders Cardiac tamponade	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	33.3% 1/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Cardiac disorders Pericardial effusion	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	33.3% 1/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Cardiac disorders Pericarditis	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	33.3% 1/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Gastrointestinal disorders Duodenitis	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	33.3% 1/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
General disorders Chest pain	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	33.3% 1/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	16.7% 1/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Infections and infestations Enterobacter sepsis	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	16.7% 1/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Infections and infestations Klebsiella sepsis	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	16.7% 1/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Infections and infestations Sepsis	33.3% 1/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	16.7% 1/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Infections and infestations Sinusitis fungal	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	16.7% 1/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	66.7% 2/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	33.3% 2/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Nervous system disorders Encephalopathy	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	16.7% 1/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	33.3% 1/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222
Vascular disorders Hypotension	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	0.00% 0/3 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222	16.7% 1/6 • All-Cause Mortality: Up to 12.3 months; Adverse Events: Up to 3.2 months All-cause mortality: The Full Analysis Set consisted of all enrolled participants; Adverse events: The Safety Analysis Set consisted of all participants treated with any dose of KITE-222