72 Participants Needed

NKX019 for Systemic Sclerosis

Recruiting at 8 trial locations
EK
NC
Overseen ByNkarta Central Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Nkarta, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the NKX019 trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have an inadequate response or intolerance to certain treatments, which might imply that some medications could be continued. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment NKX019 for Systemic Sclerosis?

Research suggests that natural killer (NK) cells play a role in the immune response in systemic sclerosis, and treatments involving NK cells, like NKX019, may help modulate this response. Additionally, studies on stem cell transplantation, which also involves immune modulation, have shown promise in improving symptoms in systemic sclerosis.12345

How is the treatment NKX019 unique for systemic sclerosis?

NKX019 is unique because it uses allogeneic CAR NK cells, which are natural killer cells modified to target CD19, a protein often found on certain cells. Unlike other treatments, these NK cells can be used 'off the shelf' from donors, potentially offering a new approach for conditions like systemic sclerosis where standard treatments may not exist.678910

What is the purpose of this trial?

This is an open-label, multi-center, multi-cohort, non-randomized Phase 1 study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with Immune-Mediated Diseases (IMD) including systemic sclerosis \[SSc\], idiopathic inflammatory myopathies \[IIM\], and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis \[AAV\].

Research Team

DS

David Shook

Principal Investigator

Nkarta, Inc.

Eligibility Criteria

This trial is for people with certain immune-mediated diseases like systemic sclerosis, inflammatory muscle diseases, and ANCA-associated vasculitis. Participants should meet specific health criteria to be eligible.

Inclusion Criteria

I have tried at least one treatment for SSc without success or could not tolerate it.
My skin is significantly hard due to my condition.
My blood test shows high levels of anti-nuclear antibodies.
See 2 more

Exclusion Criteria

My kidney function is reduced.
I have a history of HIV, Hepatitis B or C, or active tuberculosis.
My heart, immune system, and any past cancers or surgeries do not prevent me from joining.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive a cycle consisting of single-agent lymphodepletion with cyclophosphamide followed by three doses of NKX019

4 weeks
Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years
Regular visits at 3, 6, and 12 months

Treatment Details

Interventions

  • Cyclophosphamide
  • NKX019
Trial Overview The study tests NKX019, a type of therapy using modified natural killer cells targeting CD19, along with Cyclophosphamide in patients with immune system-related conditions. It's an early-phase trial to assess safety.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: NKX019 - CAR NK cell therapyExperimental Treatment3 Interventions
Phase 1: NKX019 plus fludarabine and cyclophosphamide

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nkarta, Inc.

Lead Sponsor

Trials
4
Recruited
300+

Findings from Research

In a study of 50 patients with systemic sclerosis (SSc), researchers found a significant decrease in the absolute number of NK-T cells and T cells expressing g/d TCR, which may contribute to a weakened immune response in these patients.
The study also revealed that lower NK-T cell counts correlated with higher inflammation markers, suggesting that the impairment of these immune cells could play a role in the disease's immunological and inflammatory processes.
Reduced circulating natural killer T cells and gamma/delta T cells in patients with systemic sclerosis.Riccieri, V., Parisi, G., Spadaro, A., et al.[2005]
Patients with systemic sclerosis (SSc) have normal levels of T lymphocytes and natural killer (NK) cells, but their ability to generate immune effector cells, specifically lymphokine-activated killer (LAK) cells, is significantly impaired.
This study, involving 34 SSc patients categorized by disease duration and type, highlights that despite normal cell counts, the poor LAK cell function suggests a compromised immune response to interleukin-2 in SSc patients.
Lymphokine-activated killer cell and natural killer cell activities in patients with systemic sclerosis.Kantor, TV., Whiteside, TL., Friberg, D., et al.[2019]
Autologous Hematopoietic Stem Cell Transplantation (AHSCT) shows promise in improving survival and reducing skin and lung fibrosis in patients with rapidly progressive Systemic Sclerosis (SSc), with a study involving 46 patients indicating that certain genetic factors related to HLA-E and HLA-G may influence treatment response.
Higher levels of soluble HLA-E were linked to worse disease severity, while efficient inhibition of Natural Killer (NK) cells, indicated by high expression of HLA-C alleles, correlated with better clinical outcomes after AHSCT, suggesting that immune modulation plays a critical role in treatment efficacy.
Non-Classical HLA Determinants of the Clinical Response after Autologous Stem Cell Transplantation for Systemic Sclerosis.Boukouaci, W., Lansiaux, P., Lambert, NC., et al.[2022]

References

Reduced circulating natural killer T cells and gamma/delta T cells in patients with systemic sclerosis. [2005]
Lymphokine-activated killer cell and natural killer cell activities in patients with systemic sclerosis. [2019]
Non-Classical HLA Determinants of the Clinical Response after Autologous Stem Cell Transplantation for Systemic Sclerosis. [2022]
Allogeneic marrow transplantation in patients with severe systemic sclerosis: resolution of dermal fibrosis. [2018]
Predictive factors for treatment-related mortality and major adverse events after autologous haematopoietic stem cell transplantation for systemic sclerosis: results of a long-term follow-up multicentre study. [2020]
CAR-Expressing Natural Killer Cells for Cancer Retargeting. [2020]
CD3+/CD19+-depleted grafts in HLA-matched allogeneic peripheral blood stem cell transplantation lead to early NK cell cytolytic responses and reduced inhibitory activity of NKG2A. [2020]
NK cells play a critical role in the regulation of class I-deficient hemopoietic stem cell engraftment: evidence for NK tolerance correlates with receptor editing. [2019]
The Aryl Hydrocarbon Receptor Antagonist StemRegenin1 Improves In Vitro Generation of Highly Functional Natural Killer Cells from CD34(+) Hematopoietic Stem and Progenitor Cells. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Intrinsic Functional Potential of NK-Cell Subsets Constrains Retargeting Driven by Chimeric Antigen Receptors. [2019]
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