Natural Killer Cell (CYNK-001) Infusions in Adults with AML (NCT04310592) | Clinical Trial Compass
TerminatedPhase 1
Natural Killer Cell (CYNK-001) Infusions in Adults with AML
Stopped: Business reasons
United States27 participantsStarted 2020-03-12
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Number of Participants who experience a Dose-limiting Toxicity (DLT) in MRD positive AML patients
Timeframe: Day +28
2
Number of Participants who experience a Dose-limiting Toxicity (DLT) in Relapsed/Refractory AML patients
Timeframe: Day +28
3
Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in MRD positive AML patients
Timeframe: up to 28 days
4
Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in Relapsed/Refractory AML patients