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

  • Interventional
  • Recruiting
  • NCT04623944
Eligibility Details Visit Clinicaltrials.gov

A Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias

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

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.


Age Group
18 Years and up

Accepting Healthy Volunteers?

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

At a Glance

National Government IDNCT04623944


Lead SponsorNkarta Inc.

Lead PhysicianHongtao Liu


18 Years and up