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 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).
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 subjects with r/r AML.
The secondary objectives of this study are as follows:
-to evaluate the efficacy of KITE-222 in treating subjects with r/r AML
-to evaluate the pharmacokinetic and pharmacodynamic profiles of KITE-222 in subjects with r/r AML
The exploratory objectives of this study are as follows:
-to explore the percentage CLL-1 expression on AML blasts from subjects at enrollment, and to determine if the expression correlates with the response
-to explore the phenotypic and functional characteristics of KITE-222
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, as defined in protocol.
Adequate renal, hepatic, pulmonary and cardiac function as defined in protocol.
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
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
Live vaccine received within 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
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