Myelodysplastic Syndrome Clinical Trial
NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
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.
ECOG performance status ≤2
For AML subjects:
Previously treated relapsed/refractory AML, including subjects with MRD+ disease
Received at most 3 lines of previous anti-leukemia therapy
For subjects with targetable fms-like tyrosine kinase 3 (FLT3)-mutated or isocitrate dehydrogenase (IDH)1/2 mutated disease, subjects must have received at least 1 prior respective targeted therapy and may receive up to 4 lines of prior therapy
White blood cell count of ≤25 × 10^9/L
For groups receiving NKX101 after lymphodepletion with fludarabine/cyclophosphamide +/- decitabine: Disease localized to the bone marrow, as evidenced by ≤ 5% peripheral blasts and no evidence of extramedullary disease
For groups receiving NKX101 after lymphodepletion with fludarabine/ cyclophosphamide +/- decitabine, group receiving NKX101 after lymphodepletion with fludarabine/ara-C: Additional subjects with specifically high-risk genetic mutations may be enrolled. High risk genetic mutation per ELN 2022 should be evaluated as per local assay and discussed with the Sponsor prior to study entry
For groups receiving NKX101 after lymphodepletion with fludarabine/cyclophosphamide +/- decitabine, group receiving NKX101 after lymphodepletion with fludarabine/ara-C: Additional subjects who have relapsed following HCT may be enrolled.
For MDS subjects:
Intermediate-, high-, or very high-risk MDS
Previously treated relapsed/refractory MDS
Received at least 1 and at most 3 lines of previous standard anti-MDS therapy
For groups receiving NKX101 after lymphodepletion with fludarabine/ cyclophosphamide +/- decitabine: Additional subjects with specifically high-risk disease may be enrolled. High-risk genetic mutation should be evaluated as per local assay
For group receiving lymphodepletion with fludarabine/cyclophosphamide +/- decitabine and NKX101: Additional subjects who have relapsed following HCT may be enrolled.
Adequate Organ Function
Platelet count ≥30,000/uL (platelet transfusions acceptable)
Signed informed consent
Agree to use an effective barrier method of birth control
Acute promyelocytic leukemia with t(15;17) (q22;q12); or abnormal promyelocytic leukemia/retinoic acid receptor alpha (APML-RARA) and AML arising from chronic myelomonocytic leukemia (CMML)
Evidence of leukemic meningitis or known active central nervous system disease
Peripheral leukocytosis with ≥ 20,000 blasts/μL or other evidence of rapidly progressive disease that would preclude subject from completing at least 1 cycle of treatment
Use of any anti-AML/MDS chemotherapeutic or targeted small molecule drug within protocol specified window prior to the first dose of NKX101
Presence of residual non-hematologic toxicity from prior therapies that has not resolved to ≤ Grade 1
Any hematopoietic cell transplantation within 16 weeks
Other comorbid conditions and concomitant medications prohibited as per study protocol
Pregnant or lactating female
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