NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
Leukemia
Myelodysplastic Syndromes (MDS)
18 Years and older, Male and Female
NKX101-101 (primary)
NCI-2020-11394
Summary
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.
Objectives
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.
Eligibility
- General:
- ECOG performance status =2
- Disease related:
- 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)
- Other:
- Signed informed consent
- Agree to use an effective barrier method of birth control
Treatment Sites in Georgia
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