NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers

  • End date
    Jul 24, 2038
  • participants needed
  • sponsor
    Nkarta Inc.
Updated on 24 March 2022
platelet count
monoclonal antibodies
measurable disease
lymphocytic leukemia
white blood cells
monoclonal antibody therapy
chemotherapy regimen
monoclonal protein
indolent lymphoma
refractory non-hodgkin's lymphoma
b-cell small lymphocytic lymphoma


This is a single arm, open-label, multi-center, Phase 1 study to determine the safety and tolerability of an experimental therapy called NKX019 (allogeneic CAR NK cells targeting CD19) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B cell acute lymphoblastic leukemia (B-ALL)


This is a dose-finding study of NKX019 and will be conducted in 2 parts:

Part 1: dose finding utilizing a "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 large B cell lymphoma (LBCL), mantle cell lymphoma (MCL), indolent lymphoma (IL), Waldenström macroglobulinemia (WM), CLL/ small lymphocytic lymphoma (SLL), and B-ALL.

Condition Lymphoma, Non-Hodgkin, B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma, Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Aggressive Lymphoma, Large-cell Lymphoma
Treatment NKX019
Clinical Study IdentifierNCT05020678
SponsorNkarta Inc.
Last Modified on24 March 2022


Yes No Not Sure

Inclusion Criteria

ECOG performance status ≤1
• Disease Related
Have a histologically or cytologically confirmed diagnosis of r/r B cell NHL or CLL or B-ALL as defined by WHO 2016 classification
Subjects who received prior CD19-directed therapy must have disease that remains CD19+
Have measurable disease
Have received ≥2 lines of therapy except subjects with MCL and WM, who must have received at least 1 prior line of therapy
Have received a combination of an anti CD20 monoclonal antibody and cytotoxic chemotherapy for subjects with NHL
BTKi for subjects with MCL, CLL/SLL, WM, and other indications where a BTKi is approved
Venetoclax for subjects with CLL/SLL
Tyrosine kinase inhibitor for subjects with Philadelphia chromosome (Ph+) B-ALL
Not responded or relapsed within 12 months of completion of their prior line of
Adequate organ function
therapy, with the exception of a newly diagnosed Richter's transformation of
CLL/SLL or other transformation of an indolent lymphoma, including from WM
White blood cell count of ≤20 × 109/L
Platelet count ≥30,000/uL

Exclusion Criteria

Burkitt Lymphoma, primary CNS lymphoma, Richter's transformation to Hodgkin lymphoma
• Disease related
Subjects with WM who underwent plasmapheresis <35 days prior to the first dose of NKX019
Subjects with NHL with any evidence of active CNS malignancy
Subjects with B-ALL who have extramedullary disease (EMD)
Subjects with any prior cellular therapy except subjects enrolling in selected LBCL expansion cohort who must have received prior CD19 directed CAR T therapy, recent HCT, or complications from HCT
Recent use of any cancer-directed therapy within protocol specified window prior to the first dose of NKX019
Other comorbid conditions and concomitant medications prohibited as per study protocol
Pregnant or lactating female
Residual toxicities ≥Grade 2 due to prior therapy
Clear my responses

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