NKX019 for Systemic Sclerosis
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive a cycle consisting of single-agent lymphodepletion with cyclophosphamide followed by three doses of NKX019
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- NKX019
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nkarta, Inc.
Lead Sponsor