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

  • STATUS
    Recruiting
  • End date
    Jan 10, 2039
  • participants needed
    40
  • sponsor
    Kite, A Gilead Company
Updated on 10 August 2022
fludarabine
cyclophosphamide
ejection fraction
gilbert's syndrome
refractory acute myeloid leukemia (aml)
secondary acute myeloid leukemia

Summary

The primary objective of this study is to evaluate the feasibility, safety, maximum tolerated dose (MTD), and optimal dose of KITE-222 in the treatment of participants with relapsed/refractory (r/r) acute myeloid leukemia (AML).

Details
Condition Acute Myeloid Leukemia
Treatment cyclophosphamide, Fludarabine, KITE-222
Clinical Study IdentifierNCT04789408
SponsorKite, A Gilead Company
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 allo-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
Contraception: males and females of childbearing potential must agree to use an
Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
effective method of contraception

Exclusion Criteria

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
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
Inability to tolerate prophylactic antifungal and antibacterial therapy
Live vaccine received within the ≤ 4 weeks before enrollment, or anticipation of the need for a live vaccination during the course of the study
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
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