Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia

NCT04789408 | Terminated Phase 1 Results FDA Drug

• 3 other identifiers: KT-US-486-02012020-000962-402023-507748-35
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 9

Brief 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).

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 28 days

Secondary Outcomes (20)

• Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)

  Up to 3.2 months

• Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value

  Up to 3.2 months

• Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value

  Up to 3.2 months

• Time to Neutrophil Recovery

  Up to 3.2 months

• Time to Platelet Recovery

  Up to 3.2 months

Study Arms (4)

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.

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.

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.

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.

Drug: Cyclophosphamide; Drug: Fludarabine; Biological: KITE-222

Interventions

Cyclophosphamide DRUG

Administered intravenously

Cohort 1: KITE-222 (Low Dose); Cohort 2: KITE-222 (Higher Dose); Cohort 3: KITE-222 (Highest Dose); Dose Expansion

Fludarabine DRUG

Administered intravenously

Cohort 1: KITE-222 (Low Dose); Cohort 2: KITE-222 (Higher Dose); Cohort 3: KITE-222 (Highest Dose); Dose Expansion

KITE-222 BIOLOGICAL

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

Cohort 1: KITE-222 (Low Dose); Cohort 2: KITE-222 (Higher Dose); Cohort 3: KITE-222 (Highest Dose); Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Kite, A Gilead Company: lead

Study Sites (9)

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center/James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

CHU de Toulouse Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 3110, France

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Medical Information
• Organization: Kite, A Gilead Company

medinfo@kitepharma.com

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

Study Officials

• Kite Study Director

  Kite, A Gilead Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: July 19, 2021
• Primary Completion: May 18, 2024
• Study Completion: May 18, 2024
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); FR (2)