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Relapsed/Refractory AMLPhase 1NCT04623944

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

A Phase 1 study testing NKX101 - CAR NK cell therapy in people with Relapsed/Refractory AML and AML, Adult, run by Nkarta, Inc. at 8 sites in United States.

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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory AML, AML, Adult, MDS
What is being tested?
NKX101 - CAR NK cell therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
8 sitesUnited States
Study dates
21 Sep 2020to Jul 2039
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:
  • ECOG performance status ≤2
  • Disease related:
  • For AML subjects:
  • Previously treated relapsed/refractory AML, including subjects with MRD+ disease
  • Received at most 3 lines of previous anti-leukemia therapy
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  • For subjects with targetable 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 4 lines of prior therapy
  • White blood cell count of ≤25 × 10^9/L
  • For groups receiving NKX101 after lymphodepletion with fludarabine/cyclophosphamide +/- decitabine: Disease localized to the bone marrow, as evidenced by ≤ 5% peripheral blasts and no evidence of extramedullary disease
  • For groups receiving NKX101 after lymphodepletion with fludarabine/ cyclophosphamide +/- decitabine, group receiving NKX101 after lymphodepletion with fludarabine/ara-C: Additional subjects with specifically high-risk genetic mutations may be enrolled. High risk genetic mutation per ELN 2022 should be evaluated as per local assay and discussed with the Sponsor prior to study entry
  • For groups receiving NKX101 after lymphodepletion with fludarabine/cyclophosphamide +/- decitabine, group receiving NKX101 after lymphodepletion with fludarabine/ara-C: Additional subjects who have relapsed following HCT may be enrolled.
  • For MDS subjects:
  • Intermediate-, high-, or very high-risk MDS
  • Previously treated relapsed/refractory MDS
  • Received at least 1 and at most 3 lines of previous standard anti-MDS therapy
  • For groups receiving NKX101 after lymphodepletion with fludarabine/ cyclophosphamide +/- decitabine: Additional subjects with specifically high-risk disease may be enrolled. High-risk genetic mutation should be evaluated as per local assay
  • For group receiving lymphodepletion with fludarabine/cyclophosphamide +/- decitabine and NKX101: Additional subjects who have relapsed following HCT may be enrolled.
  • 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

Who cannot join

  • Disease related:
  • Acute promyelocytic leukemia with t(15;17) (q22;q12); or abnormal promyelocytic leukemia/retinoic acid receptor alpha (APML-RARA) and AML arising from chronic myelomonocytic leukemia (CMML)
  • 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
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  • Any hematopoietic cell transplantation within 16 weeks
  • Other comorbid conditions and concomitant medications prohibited as per study protocol
  • Other:
  • Pregnant or lactating female

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Cleveland Clinic - Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • MD Anderson Cancer Center, University of Texas

    Houston, Texas, 77030

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Sarah Cannon at TriStar Bone Marrow Transplant Center

    Nashville, Tennessee, 37203

  • Methodist Healthcare System of San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
NKX101 - CAR NK cell therapy
Keywords
NKG2D, CAR, Allogeneic, Natural killer, ACR, NKX101, IL15, Interleukin 15, NK cell, Cell Therapy, Immunotherapy, Adoptive cell therapy, r/r AML, Off-the-shelf
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

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

  • NKX101 - CAR NK cell therapyBiological

    Also called Cyclophosphamide, Fludarabine, Cytarabine (ara-C), Decitabine

    NKX101 is an investigational allogeneic CAR NK product targeting NKG2D ligands on cancer cells. Part 2 will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX101 as determined in Part 1.

Study groups in NCT04623944
Study groupRoleWhat they receive
NKX101 - CAR NK cell therapyExperimentalAll subjects in Part 1 will receive lymphodepletion with fludarabine/cyclophosphamide followed by 3 or 2 (Regimen A or B, respectively) weekly doses of NKX101. Subjects in Part 2 will receive lymphodepletion with either fludarabine/cyclophosphamide or fludarabine/cytarabine (ara-C), or if the optional arm is opened, lymphodepletion with fludarabine/cyclophosphamide and decitabine, followed by 3 weekly doses of NKX101. Part 2: unrelated off-the-shelf donor derived NKX101 will be used.
Receives: Biological: NKX101 - CAR NK cell therapy

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 NKX101

  2. Response rate to NKX101 (for Part 2)

    Responses will be assessed per modified ELN criteria and will include complete and partial remission with and without varying degrees of hematologic recovery

    Measured: 28 days from first dose of NKX101

Secondary outcomes (4)

  1. Assessment of NKX101 half-life

    Time required for 50% reduction from maximum amount of circulating NKX101

    Measured: 28 days from first dose of NKX101

  2. NKX101 duration of persistence

    Testing NKX101 in peripheral blood every 3 months after dosing to determine persistence

    Measured: Followed up to 2 years after last dose of NKX101

  3. Evaluation of host immune response against NKX101

    Serum samples will be measured for antibodies against NKX101

    Measured: Followed up to 2 years after last dose of NKX101

  4. Response rate to NKX101

    Time-to-first response, time-to-best response, duration of response, transfusion independent rate, bridge-to-transplant rate, event-free survival, progression-free survival (PFS), overall survival (OS) (for all subjects), and hematologic improvement rates (for subjects with myelodysplastic syndrome [MDS])

    Measured: Primary assessment: 28 days after first dose of NKX101 followed up to 2 years after last dose of NKX101

Timeline

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

  1. First posted10 Nov 2020
  2. Study start21 Sep 2020
  3. Primary completion2 Oct 2024
  4. Study completionJul 2039 (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
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04623944
Sponsor's protocol ID
NKX101-101
Status last verified
Dec 2024
First submitted
25 Sep 2020
Last updated
27 Dec 2024
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 NKX101 - CAR NK cell therapy in people with Relapsed/Refractory AML and AML, Adult, run by Nkarta, Inc. at 8 sites in United States.

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 22 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in 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 NKX101). The study lists 2 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 NCT04623944.

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 27 Dec 2024.

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