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Lymphoma, Non-HodgkinPhase 1NCT05020678

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

A Phase 1 study testing NKX019 in people with Lymphoma, Non-Hodgkin and B-cell Acute Lymphoblastic Leukemia, run by Nkarta, Inc. at 6 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NKX019
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
6 sitesin 2 countries
Study dates
20 Aug 2021to Dec 2038
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Australia4 sites

  • Royal Brisbane and Woman's Hospital

    Brisbane, Queensland, 4029

  • Institute of Haematology, Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

United States2 sites

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

Other trials in United States

About this study

Official title: 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)

Read the 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.

Being tested
NKX019
Keywords
CD19, CAR, Allogeneic, Natural killer, ACR, NKX019, IL15, Interleukin 15, NK cell, Cell Therapy, Immunotherapy, Adoptive cell therapy, r/r NHL, r/r B-ALL, r/r MCL, r/r IL, r/r WM, r/r CLL, r/r SLL, Aggressive lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Burkitt Lymphoma, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia, Leukemia, Lymphocytic, Chronic, B-Cell, Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NKX019Biological

    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.

Study groups in NCT05020678
Study groupRoleWhat they receive
NKX019 - CAR NK cell therapyExperimentalAll 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.
Receives: Biological: NKX019

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    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.

    Measured: 30 days after last dose of NKX019

  2. Proportion of subjects experiencing dose-limiting toxicities of NKX019

    DLTs are defined as adverse events attributable to NKX019 treatment that occur during Cycle 1 and meet protocol-specified criteria

    Measured: 28 days from first dose of NKX019

  3. Objective response rate to NKX019 in Part 2

    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.

    Measured: Primary assessment: 28 days after the first dose of NKX019 followed up to 2 years after the last dose of NKX019]

Secondary outcomes (4)

  1. Assessment of NKX019 half-life

    Time required for 50% reduction from maximum amount of circulating NKX019

    Measured: Time Frame: 28 days from first dose of NKX019

  2. NKX019 duration of persistence

    Testing NKX019 in peripheral blood every 3 months after dosing to determine persistence

    Measured: Followed up to 2 years after last dose of NKX019

  3. Evaluation of host immune response against NKX019

    Serum samples will be measured for antibodies against NKX019

    Measured: Followed up to 2 years after last dose of NKX019

  4. Objective response rate to NKX019 in Part 1

    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.

    Measured: Primary assessment: 28 days after first dose of NKX019 followed up to 2 years after last dose of NKX019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start20 Aug 2021
  3. Primary completion31 Mar 2025
  4. Study completionDec 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05020678
Sponsor's protocol ID
NKX019-101
Status last verified
Apr 2026
First submitted
20 Aug 2021
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NKX019 in people with Lymphoma, Non-Hodgkin and B-cell Acute Lymphoblastic Leukemia, run by Nkarta, Inc. at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 30 days after last dose of NKX019). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05020678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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