Acute Myeloid LeukemiaPhase 1NCT04789408
Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing Cyclophosphamide, Fludarabine and KITE-222 in people with Acute Myeloid Leukemia, run by Kite, A Gilead Company at 9 sites in 2 countries.
Trial summary
The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Cyclophosphamide, Fludarabine and KITE-222
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 19 Jul 2021to 18 May 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML)
- Morphological disease in the bone marrow and/or peripheral blood within 28 days before enrollment
- Prior exposure to the relevant agent class for individuals with AML characterized by a mutation targeted by an approved therapy
- Institutional criteria for allogeneic (allo) - stem cell transplant (SCT) fitness must be met: individuals must have an identified stem-cell donor readily available for potential allo-SCT after therapy with KITE-222
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic status, defined as:
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- Absolute neutrophil count (ANC) ≥ 1000/µL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia
- Platelet count ≥ 50,000/µL unless, in the opinion of the investigator, thrombocytopenia is due to underlying leukemia
- Absolute lymphocyte count (ALC) ≥ 100/µL
- Adequate renal, hepatic, pulmonary and cardiac function defined as:
- Creatinine clearance (as estimated by the Cockcroft Gault formula) ≥ 60 mL/min
- Serum alanine aminotransferase/aspartate aminotransferase ≤ 2.5 x upper limit of normal
- Total bilirubin ≤ 1.5 mg/dL, except in individuals with Gilbert's syndrome
- Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
- Baseline oxygen saturation > 92% on room air and no clinically significant pleural effusion as determined by chest imaging
- Contraception: males and females of childbearing potential must agree to use an effective method of contraception
- Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
Who cannot join
- Diagnosis of acute promyelocytic leukemia
- Auto-SCT within the 6 weeks before enrollment
- Donor Lymphocyte Infusions (DLI) within 28 days prior to enrollment
- Any drug used for graft-versus-host-disease (GVHD) within 4 weeks prior to enrollment
- Acute GVHD grade II-IV by Mount Sinai Acute GVHD International Consortium criteria
- Active central nervous system (CNS) disease involvement
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- Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) or the possible requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, spinal cord compression, bowel obstruction, leukostasis, or TLS) at the time of enrollment or KITE-222 infusion
- History of C-type lectin-like molecule-1 (CLL-1)-directed therapy or genetically modified T-cell therapy
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free for at least 3 years after the last definitive therapy
- History of severe hypersensitivity reaction to aminoglycosides
- History of concomitant genetic syndrome associated with bone marrow failure
- Individuals with a genetic syndrome that increases the risk of allo-SCT, including Down syndrome (trisomy 21)
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment
- Individuals with cardiac atrial or ventricular leukemia involvement
- History of symptomatic deep vein thrombosis (DVT) or a pulmonary embolism within 6 months of enrollment. History of upper extremity line related DVT within the 3 months of conditioning chemotherapy.
- Primary immunodeficiency disorders
- History of a human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection
- History of an autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression or systemic disease modifying agents within the last 2 years
- History or presence of a CNS disorder
- Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management
- Live vaccine received within the ≤ 4 weeks before enrollment, or anticipation of the need for a live vaccination during the course of the study
- Inability to tolerate prophylactic antifungal and antibacterial therapy
- Presence of any indwelling line or drain
- Ongoing Grade 2 or higher toxicities from previous therapies, excluding hematologic toxicities
- Females of childbearing potential who are pregnant or breastfeeding
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center/James Cancer Hospital
Columbus, Ohio, 43210
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
France2 sites
Institut Paoli-Calmettes
Marseille, 13009
CHU de Toulouse Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 3110
About this study
Official title: A Phase 1 Open-label, Multicenter Study Evaluating the Safety of KITE-222, an Autologous Anti-CLL-1 CAR T-cell Therapy, in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Cyclophosphamide, Fludarabine, KITE-222
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Administered intravenously
FludarabineDrug
Administered intravenously
KITE-222Biological
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: KITE-222 (Low Dose) | Experimental | Participants with relapsed or refractory (r/r) acute myeloid leukemia (AML) will receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single infusion of KITE-222 chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously (IV) at a low dose on Day 0 based on participants body weight. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-222 |
| Cohort 2: KITE-222 (Higher Dose) | Experimental | Participants with r/r AML will receive 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. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-222 |
| Cohort 3: KITE-222 (Highest Dose) | Experimental | Participants with r/r AML will receive 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. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-222 |
| Dose Expansion | Experimental | Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose [at the maximum tolerated dose (MTD) determined] of KITE-222. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced Dose Limiting Toxicities (DLTs)
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.
Measured: Up to 28 days
Secondary outcomes (20)
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to 3.2 months
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
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.
Measured: Up to 3.2 months
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
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.
Measured: Up to 3.2 months
Time to Neutrophil Recovery
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]).
Measured: Up to 3.2 months
Time to Platelet Recovery
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]).
Measured: Up to 3.2 months
Composite Complete Remission (CCR) Rate
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]).
Measured: Up to 3.2 months
Overall Remission Rate (ORR)
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%.
Measured: Up to 3.2 months
Relapse-free Survival (RFS)
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]).
Measured: Up to 3.2 months
Allogeneic Stem Cell Transplant (Allo-SCT) Rate
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.
Measured: Up to 3.2 months
Event-free Survival (EFS)
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.
Measured: Up to 12.3 months
Overall Survival (OS)
OS was defined as the time from KITE-222 infusion to the date of death from any cause.
Measured: Up to 12.3 months
All-cause Mortality Within 30 Days of KITE-222 Infusion
The mortality was calculated by number of deaths, regardless of cause, within 30 days from the KITE-222 infusion date.
Measured: Up to 30 days
All-cause Mortality Within 60 Days of KITE-222 Infusion
The mortality was calculated by number of deaths, regardless of cause, within 60 days from the KITE-222 infusion date.
Measured: Up to 60 days
Pharmacokinetics (PK) Parameter: Peak Level of KITE-222 CAR T Cells in Blood
Peak was defined as the maximum number of CAR T cells in blood measured after infusion.
Measured: Baseline (Day 0), post dose on Days 3, 7,10, Weeks 2, 3, 4, and 6
PK Parameter: Area Under the Curve for the Blood Level of KITE-222 CAR T Cells From Day 0 to Day 28 (AUC0-28)
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.
Measured: Baseline (Day 0), post dose on Days 3, 7, 10, Weeks 2, 3, and 4
Pharmacodynamics (PD) Parameter: Peak Serum Levels of Interferon-gamma (IFNg), Interleukin (IL)-12 P40, IL-10, and IL-15
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.
Measured: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4
PD Parameter: Peak Serum Levels of IL-2 R Alpha and Ferritin
Peak was defined as the maximum levels of IL-2 R Alpha and Ferritin in serum from baseline to Week 4.
Measured: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4
PD Parameter: AUC0-28 for the Serum Levels IFNg, IL-12 P40, IL-10, and IL-15 in Serum
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.
Measured: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4
PD Parameter: AUC0-28 for the Serum Levels of IL-2 R Alpha and Ferritin
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.
Measured: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4
Percentage of Participants Who Develop Anti-KITE-222 CAR Antibodies
Measured: Up to 3.2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start19 Jul 2021
- Primary completion18 May 2024
- Study completion18 May 2024
Why it stopped: Study was terminated due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789408
- Sponsor's protocol ID
- KT-US-486-0201
- Other IDs
- 2020-000962-40, 2023-507748-35, 2023
- Status last verified
- Jun 2025
- First submitted
- 5 Mar 2021
- Last updated
- 11 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Multicenter Study Evaluating the Safety of KITE-222, an Autologous Anti-CLL-1 CAR T-cell Therapy, in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04789408
- Acronym / sponsor ID
- KT-US-486-0201
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to futility
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Posted 11 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: KITE-222 (Low Dose) | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-222Participants with relapsed or refractory (r/r) acute myeloid leukemia (AML) will receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single infusion of KITE-222 chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously (IV) at a low dose on Day 0 based on participants body weight. |
| Cohort 2: KITE-222 (Higher Dose) | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-222Participants with r/r AML will receive 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) | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-222Participants with r/r AML will receive 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. |
| Dose Expansion | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: KITE-222Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose [at the maximum tolerated dose (MTD) determined] of KITE-222. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML)
- Morphological disease in the bone marrow and/or peripheral blood within 28 days before enrollment
- Prior exposure to the relevant agent class for individuals with AML characterized by a mutation targeted by an approved therapy
- Institutional criteria for allogeneic (allo) - stem cell transplant (SCT) fitness must be met: individuals must have an identified stem-cell donor readily available for potential allo-SCT after therapy with KITE-222
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (26 listed)
- Diagnosis of acute promyelocytic leukemia
- Auto-SCT within the 6 weeks before enrollment
- Donor Lymphocyte Infusions (DLI) within 28 days prior to enrollment
- Any drug used for graft-versus-host-disease (GVHD) within 4 weeks prior to enrollment
- Acute GVHD grade II-IV by Mount Sinai Acute GVHD International Consortium criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAdministered intravenously | Drug | Cohort 1: KITE-222 (Low Dose), Cohort 2: KITE-222 (Higher Dose), Cohort 3: KITE-222 (Highest Dose), Dose Expansion |
| FludarabineAdministered intravenously | Drug | Cohort 1: KITE-222 (Low Dose), Cohort 2: KITE-222 (Higher Dose), Cohort 3: KITE-222 (Highest Dose), Dose Expansion |
| KITE-222A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously | Biological | Cohort 1: KITE-222 (Low Dose), Cohort 2: KITE-222 (Higher Dose), Cohort 3: KITE-222 (Highest Dose), Dose Expansion |
Primary outcome
Percentage of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
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.
20 secondary outcomes
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 3.2 months
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Time frame: Up to 3.2 months
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Time frame: Up to 3.2 months
Time to Neutrophil Recovery
Time frame: Up to 3.2 months
Time to Platelet Recovery
Time frame: Up to 3.2 months
Composite Complete Remission (CCR) Rate
Time frame: Up to 3.2 months
Overall Remission Rate (ORR)
Time frame: Up to 3.2 months
Relapse-free Survival (RFS)
Time frame: Up to 3.2 months
Allogeneic Stem Cell Transplant (Allo-SCT) Rate
Time frame: Up to 3.2 months
Event-free Survival (EFS)
Time frame: Up to 12.3 months
Overall Survival (OS)
Time frame: Up to 12.3 months
All-cause Mortality Within 30 Days of KITE-222 Infusion
Time frame: Up to 30 days
All-cause Mortality Within 60 Days of KITE-222 Infusion
Time frame: Up to 60 days
Pharmacokinetics (PK) Parameter: Peak Level of KITE-222 CAR T Cells in Blood
Time frame: Baseline (Day 0), post dose on Days 3, 7,10, Weeks 2, 3, 4, and 6
PK Parameter: Area Under the Curve for the Blood Level of KITE-222 CAR T Cells From Day 0 to Day 28 (AUC0-28)
Time frame: Baseline (Day 0), post dose on Days 3, 7, 10, Weeks 2, 3, and 4
Pharmacodynamics (PD) Parameter: Peak Serum Levels of Interferon-gamma (IFNg), Interleukin (IL)-12 P40, IL-10, and IL-15
Time frame: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4
PD Parameter: Peak Serum Levels of IL-2 R Alpha and Ferritin
Time frame: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4
PD Parameter: AUC0-28 for the Serum Levels IFNg, IL-12 P40, IL-10, and IL-15 in Serum
Time frame: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4
PD Parameter: AUC0-28 for the Serum Levels of IL-2 R Alpha and Ferritin
Time frame: Baseline (Day 0), post dose on Days 1, 3, 5, 7, 9, 11, 13, Weeks 2, 3, 4
Percentage of Participants Who Develop Anti-KITE-222 CAR Antibodies
Time frame: Up to 3.2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kite Study Director study director
Kite, A Gilead Company
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Fludarabine and KITE-222 in people with Acute Myeloid Leukemia, run by Kite, A Gilead Company at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.