Natural Killer Cell (CYNK-001) Infusions in Adults With AML (CYNK001AML01)

  • STATUS
    Recruiting
  • End date
    May 3, 2024
  • participants needed
    56
  • sponsor
    Celularity Incorporated
Updated on 13 June 2022
cancer
remission
hysterectomy
immunosuppressant
myeloid leukemia
flow cytometry
prednisone
immunosuppressive agents
treatment regimen
cell transplantation
bilateral oophorectomy
leukemia
bone marrow procedure
minimal residual disease
residual tumor
refractory acute myeloid leukemia (aml)
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 Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neoplasms by Histologic Type, Neoplasms, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Alkylating Agents, Antimetabolites, Antineoplastic, Antiviral Agents, Analgesics, Non-narcotic, Anti-infective Agents, Analgesics, Peripheral Nervous System Agents, Hematologic Diseases, Hematologic Neoplasms, Leukemia in Remission, Relapsed Adult AML, Refractory AML
Treatment CYNK-001
Clinical Study IdentifierNCT04310592
SponsorCelularity Incorporated
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

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
Relapsed AML are defined as having relapsed after achieving ≥ 1 CR, including relapse after allogeneic stem cell transplantation (≥ 2 months after transplant)
Refractory AML, defined as not achieving CR, CRi, or MLFS after 2 or more cycles of induction therapy (primary refractory) or not achieving CR after treatment for relapsed AML
Secondary AML (MDS transformation): Secondary AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML
Treatment-related AML: Treatment-related AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML
Patient with prior central nervous system involvement by malignancy are eligible
(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
provided that it has been treated and cerebral spinal fluid is clear for at
least 2 weeks prior to start of Lymphodepletion Regimen
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 condition that confounds the ability to interpret data from the study
Patient has bi-phenotypic acute leukemia
Patient has acute promyelocytic leukemia (APL)
Patient is pregnant or breastfeeding
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 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
Superficial bladder cancer
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 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
For patients with therapy-related AML, the underlying malignancy which led to
secondary AML must be stabilized (not progressing) and not under active
treatment
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
uncontrolled or progressive 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 < 40% 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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