Myelodysplastic Syndrome Clinical Trial

NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS

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

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Disease related:

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

Other:

Pregnant or lactating female

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

61

Study ID:

NCT04623944

Recruitment Status:

Active, not recruiting

Sponsor:

Nkarta Inc.

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There are 8 Locations for this study

See Locations Near You

Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
The Cleveland Clinic - Taussig Cancer Institute
Cleveland Ohio, 44195, United States
Sarah Cannon at TriStar Bone Marrow Transplant Center
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center, University of Texas
Houston Texas, 77030, United States
Methodist Healthcare System of San Antonio
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

61

Study ID:

NCT04623944

Recruitment Status:

Active, not recruiting

Sponsor:


Nkarta Inc.

How clear is this clinincal trial information?

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