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

April 15, 2026 updated by: Nkarta, Inc.

A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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 and safety lead-in to confirm dose for NKX019 in combination with rituximab expansion cohorts (as applicable) 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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Institute of Haematology, Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2010
        • St. Vincent's Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Woman's Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Center
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

General:

Eastern Cooperative Oncology Group (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/CD20-directed therapy must have disease that remains CD19+ and/or CD20+ respectively
  • Have measurable disease
  • Have received ≥2 lines of therapy except subjects with MCL, CAR T Naïve cohorts 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

  • Received:

    • 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 therapy, with the exception of a newly diagnosed Richter's transformation of CLL/SLL or other transformation of an indolent lymphoma, including from WM
  • Subjects must not have evidence of rapidly progressive disease that would preclude subject from completing at least 1 cycle of treatment.
  • Adequate organ function
  • White blood cell count of ≤20 × 109/L
  • Platelet count ≥30,000/uL

Exclusion Criteria:

• Disease related:

  • Burkitt Lymphoma, primary central nervous system (CNS) lymphoma, Richter's transformation to Hodgkin lymphoma
  • 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 cohorts who must have received prior 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
  • Residual toxicities ≥Grade 2 due to prior therapy
  • Other comorbid conditions and concomitant medications prohibited as per study protocol
  • Pregnant or lactating female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NKX019 - CAR NK cell therapy
All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by 3 weekly doses of NKX019 on Day 0, 7, and 14 of a 28-day cycle. Combination cohorts (if opened) will additionally receive rituximab with each cycle.
Biological: NKX019
NKX019 is an investigational allogeneic CAR NK product targeting CD19 on cells. The starting dose of NKX019 in Part 1 is 3 × 10^8 NK cells (6 × 10^6/kg for patients < 50 kg) administered as 3 weekly doses. Part 2 (dose expansion cohorts) will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX019 as determined in Part 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 30 days after last dose of NKX019
Incidence, nature, and severity of treatment related adverse events will be evaluated. An adverse event is any unfavorable and unintended sign including clinically significant abnormal laboratory findings, symptom or disease.
30 days after last dose of NKX019
Proportion of subjects experiencing dose-limiting toxicities of NKX019
Time Frame: 28 days from first dose of NKX019
DLTs are defined as adverse events attributable to NKX019 treatment that occur during Cycle 1 and meet protocol-specified criteria
28 days from first dose of NKX019
Objective response rate to NKX019 in Part 2
Time Frame: Primary assessment: 28 days after the first dose of NKX019 followed up to 2 years after the last dose of NKX019]
Percentage of subjects with complete and partial response. Response to treatment will be assessed based on: Lugano classification with LYRIC refinement for subjects with NHL (except CLL/SLL and WM); 2018 iwCLL guidelines for subjects with CLL/SLL; Version 1.2020 NCCN for subjects with B-ALL; consensus criteria from the 6th International Workshop on Waldenström Macroglobulinemia for subjects with WM.
Primary assessment: 28 days after the first dose of NKX019 followed up to 2 years after the last dose of NKX019]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of NKX019 half-life
Time Frame: Time Frame: 28 days from first dose of NKX019
Time required for 50% reduction from maximum amount of circulating NKX019
Time Frame: 28 days from first dose of NKX019
NKX019 duration of persistence
Time Frame: Followed up to 2 years after last dose of NKX019
Testing NKX019 in peripheral blood every 3 months after dosing to determine persistence
Followed up to 2 years after last dose of NKX019
Evaluation of host immune response against NKX019
Time Frame: Followed up to 2 years after last dose of NKX019
Serum samples will be measured for antibodies against NKX019
Followed up to 2 years after last dose of NKX019
Objective response rate to NKX019 in Part 1
Time Frame: Primary assessment: 28 days after first dose of NKX019 followed up to 2 years after last dose of NKX019
Percentage of subjects with complete and partial response. Response to treatment will be assessed based on: Lugano classification with LYRIC refinement for subjects with NHL (except CLL/SLL and WM); 2018 iwCLL guidelines for subjects with CLL/SLL; Version 1.2020 NCCN for subjects with B-ALL; consensus criteria from the 6th International Workshop on Waldenström Macroglobulinemia for subjects with WM.
Primary assessment: 28 days after first dose of NKX019 followed up to 2 years after last dose of NKX019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nkarta, Inc.

Investigators

  • Study Director: David Shook, MD, Nkarta, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2021

Primary Completion (Actual)

March 31, 2025

Study Completion (Estimated)

December 1, 2038

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKX019-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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