Clinical Trials

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

Inclusion Criteria - 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/?L 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.