Natural Killer Cell (CYNK-001) Infusions in Adults With AML

  • STATUS
    Recruiting
  • End date
    Jan 3, 2022
  • participants needed
    22
  • sponsor
    Celularity Incorporated
Updated on 11 March 2021
cancer
remission
hysterectomy
immunosuppressant
myeloid leukemia
flow cytometry
prednisone
immunosuppressive agents
treatment regimen
bilateral oophorectomy
leukemia
bone marrow procedure
minimal residual disease
residual tumor
secondary acute myeloid leukemia
blast cells
cancer treatment
primary cancer
cancer therapy

Summary

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.

Details
Condition Anti-Infective Agents, Antiviral Agents, Hematologic Malignancy, Physiological Effects of Drugs, biological response modifier, Blood disorder, Cancer, leukemia, Alkylating Agents, Acute myeloid leukemia, Myeloid Leukemia, Peripheral Nervous System Agents, Non-opioid analgesics, Analgesics, Immunosuppressive Agents, Antimetabolites, Antineoplastic, Neoplasms by Histologic Type, Cancer/Tumors, Acute Myelogenous Leukemia (AML), Ewing's Family Tumors, Leukemia (Pediatric), Cancer (Pediatric), Leukemia in Remission, Blood Cancer, Neoplasms, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, hematologic disorder, blood disorders, hematologic disorders, hematologic disease, blood diseases, hematological disease, blood dyscrasias, blood dyscrasia, haematological disorders, anti-infectives, anti-infective, anti-infective agent, antiinfective, leukemias, alkylating agent, antiviral drugs, antiviral, antivirals, antiviral drug, analgesic, analgesic drugs, pain medication, pain killers, analgesic agents, pain medicine, painkillers, anodyne, myelogenous leukemia, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies, immunosuppressant, immunosuppressive, immunosuppressants, immunosuppressives
Treatment CYNK-001
Clinical Study IdentifierNCT04310592
SponsorCelularity Incorporated
Last Modified on11 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Leukemia (Pediatric) or Peripheral Nervous System Agents or Immunosuppressive Agents or Myeloid Leukemia or Neoplasms or Cancer (Pediatric) or biologi...?
Do you have any of these conditions: leukemias or pain medication or Analgesics or hematologic disorder or Alkylating Agents or hematological disease or hematologic disease or blood disea...?
Do you have any of these conditions: Alkylating Agents or anti-infective or Hematological Disorders or hematological disease or pain medication or Blood Cancer or Neoplasms or hematologic...?
Do you have any of these conditions: Anti-Infective Agents or Myeloid Leukemia or antiviral drug or pain killers or Cancer or blood dyscrasia or hematologic disorders or analgesic agents ...?
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)
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
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
FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
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

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 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase 2.5 x the upper limit of normal (ULN)
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease Study equation (Levey, 2006) or history of an abnormal eGFR < 60 and a decline of > 15 mL/min/1.73 m2 below normal in the past year
Patient has a bilirubin level > 2 mg/dL (unless Patient has known Gilbert's disease)
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 as part of their anti-AML treatment prior to first CYNK-001 infusion or plans to have transplant within the 28 day period following first CYNK-001 infusion. Exception includes relapsed patients who received prior Bone Marrow transplant as part of their treatment plan at initial diagnosis
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
Basal cell carcinoma of the skin
Squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Carcinoma in situ of the breast
Incidental biological finding of prostate cancer (TNM stage of T1a or T1b)
Patient has a history of severe asthma and is presently on chronic medications or has a history of other symptomatic pulmonary disease
Patient has uncontrolled graft versus host disease (GVHD) or GVHD requiring treatment with corticosteroids
Patient has an untreated chronic infection or has received treatment of any infection with systemic antibiotics within 2 weeks prior to first CYNK-001 infusion. Prophylactic antibiotic, antiviral, and antifungal medication are permissible
Patient has any other organ dysfunction (CTCAE Version 5.0 Grade 3 or greater) that will interfere with the administration of the therapy according to this protocol
Patient has a resting left ventricular ejection fraction (LVEF) of < 45% obtained by echocardiography or multi-gated acquisition scan (MUGA)
Patient was treated with an investigational product within 28 days of first CYNK-001 infusion. Patient must no longer be a participant in the previous interventional study at the time of CYNK-001 infusion. (Patients who are under survival follow-up or observation associated with a study are permitted, and if treatment information is collected for this period, "Investigational Study" must be used to capture the study treatment.)
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