This is a single-arm, open-label, multi-center, Phase 1 study to determine safety and tolerability of an experimental therapy called NKX101 (allogeneic CAR NK cells targeting NKG2D ligands) in patients with relapsed/refractory AML or intermediate, high and very high risk relapsed/refractory MDS.
This is a dose-finding study of NKX101 and will be conducted in 2 parts: Part 1: dose finding with two dosing regimens, utilizing modified "3+3" enrollment schema. Part 2: dose expansion to further evaluate safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumor response in expansion cohorts of patients with either AML or MDS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
NKX101 is an investigational allogeneic CAR NK product targeting NKG2D ligands on cancer cells. Part 2 will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX101 as determined in Part 1.
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, nature, and severity of treatment related adverse events will be evaluated. An adverse event is any unfavorable and unintended sign including clinically significant abnormal laboratory findings, symptom or disease.
Time frame: 30 days after last dose of NKX101
Response rate to NKX101 (for Part 2)
Responses will be assessed per modified ELN criteria and will include complete and partial remission with and without varying degrees of hematologic recovery
Time frame: 28 days from first dose of NKX101
Assessment of NKX101 half-life
Time required for 50% reduction from maximum amount of circulating NKX101
Time frame: 28 days from first dose of NKX101
NKX101 duration of persistence
Testing NKX101 in peripheral blood every 3 months after dosing to determine persistence
Time frame: Followed up to 2 years after last dose of NKX101
Evaluation of host immune response against NKX101
Serum samples will be measured for antibodies against NKX101
Time frame: Followed up to 2 years after last dose of NKX101
Response rate to NKX101
Time-to-first response, time-to-best response, duration of response, transfusion independent rate, bridge-to-transplant rate, event-free survival, progression-free survival (PFS), overall survival (OS) (for all subjects), and hematologic improvement rates (for subjects with myelodysplastic syndrome \[MDS\])
Time frame: Primary assessment: 28 days after first dose of NKX101 followed up to 2 years after last dose of NKX101
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Chicago, Illinois, United States
The Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, United States
Sarah Cannon at TriStar Bone Marrow Transplant Center
Nashville, Tennessee, United States
MD Anderson Cancer Center, University of Texas
Houston, Texas, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States