NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
Relapsed/Refractory AML, AML, Adult, MDS
About this trial
This is an interventional treatment trial for Relapsed/Refractory AML focused on measuring NKG2D, CAR, Allogeneic, Natural killer, ACR, NKX101, IL15, Interleukin 15, NK cell, Cell Therapy, Immunotherapy, Adoptive cell therapy, r/r AML, Off-the-shelf
Eligibility Criteria
Inclusion Criteria:
General:
- ECOG performance status ≤2
- Haplo-matched related subjects require a suitable haplo-matched related donor, who is able and willing to undergo leukapheresis
Disease related:
For AML subjects:
- Previously treated relapsed/refractory AML, including subjects with MRD+ disease
- Received at least 1 and at most 2 lines of previous standard anti-leukemia therapy
- For subjects with 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 3 lines of prior therapy
- White blood cell count of ≤25 × 10^9/L
For MDS subjects:
- Intermediate-, high-, or very high-risk MDS
- Previously treated relapsed/refractory MDS
- Received at least 1 and at most 2 lines of previous standard anti-MDS therapy
- 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)
- 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
Sites / Locations
- Colorado Blood Cancer InstituteRecruiting
- Mayo Clinic FloridaRecruiting
- Winship Cancer Institute, Emory UniversityRecruiting
- University of Chicago Medical CenterRecruiting
- The Cleveland Clinic - Taussig Cancer InstituteRecruiting
- Sarah Cannon at TriStar Bone Marrow Transplant CenterRecruiting
- MD Anderson Cancer Center, University of TexasRecruiting
- Methodist Healthcare System of San AntonioRecruiting
Arms of the Study
Arm 1
Experimental
NKX101 - CAR NK cell therapy
All subjects in Part 1 will receive lymphodepletion with fludarabine/cyclophosphamide followed by 3 or 2 (Regimen A or B, respectively) weekly doses of NKX101. Subjects in Part 2 will receive lymphodepletion with either fludarabine/cyclophosphamide or fludarabine/cytarabine (ara-C), or if the optional arm is opened, lymphodepletion with fludarabine/cyclophosphamide and decitabine, followed by 3 weekly doses of NKX101. Part 2: unrelated off-the-shelf donor derived NKX101 will be used.