RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing NKX019 for Systemic Sclerosis

Q: Is NCT06733935 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT06733935?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT06733935?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomly assigned dose escalation and dose expansion basket study to determine the whether it is safe and how hard side effects are to live with of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.

Official registry: https://clinicaltrials.gov/study/NCT06733935 · Nkarta, Inc. · enrollment listed as 240

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are NKX019, Fludarabine, or Cyclophosphamide. The registry lists allocation as na. This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomly assigned dose escalation and dose expansion basket study to determine the whether it is safe and how hard side effects are to live with of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.

They plan to enroll about 240 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases

Interventions: NKX019, Fludarabine, Cyclophosphamide

Primary outcome (registry wording): Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability]

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Age ≥18 and ≤75 years
Women of childbearing potential must have negative pregnancy tests at screening and baseline and agree to abstinence or acceptable birth control from 2 weeks before the first dose through 1 year after the last dose
Participants taking corticosteroids must be at a stable prednisone (or equivalent) dose ≤20 mg/day for ≥14 days before Screening
Participants on immunosuppressives or immunomodulators (other than corticosteroids) must have stable dosing for ≥4 weeks before Screening
eGFR (2021 CKD-EPI equation) ≥45 mL/min/1.73 m² at screening
For Subjects with Systemic Sclerosis (SSc):
Meets the 2013 ACR/EULAR classification criteria for SSc

Who the registry excludes

Currently requiring or expected to require renal dialysis during the study
Previous solid organ or hematopoietic cell transplant, or planned transplant during the study treatment period
Congenital or acquired immunodeficiency resulting in severe infection, or receiving chronic immunoglobulin replacement therapy
Liver disease or dysfunction, including cirrhosis and/or bilirubin ≥3× the upper limit of normal
Pulmonary comorbidity (eg, COPD or asthma requiring daily oral steroids), resting hypoxemia (\<92% oxygen saturation on room air), or significant smoking history (\>10 pack-years) with active pulmonary disease
ILD requiring supplemental oxygen therapy, FVC \<45% predicted, or DLCO ≤40% predicted at screening
White blood cell count \<3,000/mm³, hemoglobin levels ≤9 g/dL, absolute neutrophil count ≤1,500/mm³, platelets ≤100,000/mm³, or blood transfusion within 60 days before lymphodepletion (LD)

Public study contact (from the registry)

Nkarta Central Contact

Only use email

clinicaltrials@nkartatx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

12 listed

Nkarta Investigational Site — Los Angeles, California (recruiting)
Nkarta Investigational Site — Plantation, Florida (recruiting)
Nkarta Investigational Site — Tampa, Florida (recruiting)
Nkarta Investigational Site — Fairway, Kansas (recruiting)
Nkarta Investigational Site — Ann Arbor, Michigan (recruiting)
Nkarta Investigational Site — Minneapolis, Minnesota (recruiting)
Nkarta Investigational Site — Hackensack, New Jersey (recruiting)
Nkarta Investigational Site — Summit, New Jersey (recruiting)
Nkarta Investigational Site — New York, New York (recruiting)
Nkarta Investigational Site — Syracuse, New York (recruiting)
Nkarta Investigational Site — Charlotte, North Carolina (recruiting)
Nkarta Investigational Site — Dallas, Texas (recruiting)

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FAQ about this NCT record

Is NCT06733935 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06733935?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06733935?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary