NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
Running, not enrolling · Phase 1
Conditions studied: Relapsed/Refractory AML, AML, Adult, MDS, Refractory Myelodysplastic Syndromes
In brief
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.
Key facts
- Study ID
- NCT04623944
- Run by
- Nkarta, Inc.
- People needed
- 61
- Starts
- 2020-09-21
- Expected to finish
- 2039-07-01
- Last updated by the study team
- 2024-12-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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 — 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.