Status and phase
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About
This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating acute myeloid leukemia.
Enrollment
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Inclusion and exclusion criteria
Treatment Eligibility Screening Patient Inclusion Criteria
Patients must satisfy the following criteria to be enrolled in the study:
Patient has eligible disease status:
Primary or Secondary acute myeloid leukemia (AML) Patients in first of second Morphological Complete Remission (CR), Morphological Complete Remission with incomplete hematologic recovery (CRi), or Morphologic Leukemia-free State (MLFS) as defined by the European LeukemiaNet (ELN) recommendations for AML Response Criteria (Dohner, 2017).
R/R diagnosis based on confirmed diagnosis with local pathology report following any reinduction/ salvage therapy ELN guidelines.
Patient with prior central nervous system involvement by malignancy are eligible provided that it has been treated and cerebral spinal fluid is clear for at least 2 weeks prior to start of Lymphodepletion Regimen.
(MRD positive population only): Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment.
For the purposes of this study, MRD positivity is defined as greater than or equal to 0.1% blasts detected by MFC on BMA by the Sponsor-selected Central MRD analysis laboratory, where assay sensitivity allows for a Lower Limit of Detection (LOD) of 1 x 10-4 (0.01%) or lower.
Patient is ≥ 18 and ≤ 80 years of age at the time of signing the Study informed consent form (ICF).
Patient understands and voluntarily signs the Study ICF prior to any study-related assessments/procedures are conducted.
Patient is willing and able to adhere to the study schedule and other protocol requirements.
Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2.
Ability to be off immunosuppressive drugs for at least 3 days prior to the CYNK-001 infusion. Steroids at the equivalent of no more than 7.5 mg prednisone per day are permissible.
Female of childbearing potential (FCBP)* must not be pregnant and agree to not becoming pregnant for at least 28 days following the CYNK-001. FCBP must agree to use an adequate method of contraception during the treatment period.
Male Patients must agree to use a condom during sexual contact for at least 28 days following the last infusion of CYNK-001, even if he has undergone a successful vasectomy.
Treatment Eligibility Screening Patient Exclusion Criteria
The presence of any of the following will exclude the Patient from enrollment:
Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the Patient from participating in the study.
Patient has any condition including the presence of laboratory abnormalities which places the Patient at unacceptable risk if he or she were to participate in the study.
Patient has any condition that confounds the ability to interpret data from the study.
Patient has bi-phenotypic acute leukemia.
Patient has acute promyelocytic leukemia (APL).
Patient has inadequate organ function as defined below at time of Treatment Eligibility Period:
Patient has had prior treatment with biologic antineoplastic agents less than 7 days before first CYNK-001 infusion and at least 5 half-lives. (Exception will be granted for monoclonal antibodies that are known to have long half-lives, in which case a minimum of 2 weeks from last dose will be required). For agents that have known AEs occurring beyond these specified days after administration, this period must be extended beyond the time during which acute AEs are known to occur. Treating physicians are encouraged to discuss cases with the Medical Monitor.
Patient is pregnant or breastfeeding.
Patient has new or progressive pulmonary infiltrates or pleural effusion large enough to be detected by chest x-ray or CT scan within 2 weeks of first CYNK-001 infusion.
Patient has active autoimmune disease other than controlled connective tissue disorder or those who are not on active therapy.
Patient has had a Bone Marrow transplant < 60 days prior to screening or plans to have a transplant within the 28 day period following the first CYNK-001 infusion.
Patient has a history of malignancy other than AML or other underlying hematologic conditions such as myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN) unless the Patient has been free of disease for greater than 3 years prior to CYNK 001 infusion. Exceptions will include the following malignancies:
Patient has a history of severe asthma and is presently on chronic medications or has a history of other symptomatic pulmonary disease.
Patient has the following prior history of GVHD:
Acute GVHD: Subjects with prior history of acute GVHD where signs and/or symptoms did not completely resolve (no clinical signs/symptoms and not on more than 7.5 mg of predinsone per day Chronic GVHD: Subjects with prior history of chronic GVHD where signs and/or symptoms did not completely resolve (no clinical signs/symptoms and not on more than 7.5 mg of prednisone per day) within 90 days of ongoing immunosuppression.
Primary purpose
Allocation
Interventional model
Masking
94 participants in 2 patient groups
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Central trial contact
Cherie Daly, MD
Data sourced from clinicaltrials.gov
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