A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)

General Inclusion Criteria:

1. Age ≥18 and ≤75

2. Signed informed consent form and ability to adhere to the study visit schedule andcomply with other protocol requirements

3. Women of childbearing potential must have negative pregnancy tests at screening andbaseline, and agree to abstinence or acceptable birth control from 2 weeks prior tothe first dose through 1 year after the last dose

4. Progression despite maximal tolerated doses of renin-angiotensin system (RAS)blockade agents

5. . For participants taking chronic corticosteroids for management of the diseaseunder study, the prednisone (or equivalent) dose must be ≤20 mg/day at 2 weeks priorto Screening and stable for ≥ 14 days before start of Screening

6. For participants on immunosuppressives or immunomodulators (other thancorticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening

LN-specific Inclusion Criteria:

1. Score of 10 or more points on the American College of Rheumatology (ACR) 2019classification criteria for SLE

2. Active biopsy proven lupus nephritis Class III or Class IV without Class V overlapusing the 2018 International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria as evidenced on kidney biopsy during consent or within 6 monthsbefore screening. The biopsy must have at least mild to moderate activity score andno more than moderate chronicity index per NIH indices

3. Active renal disease as defined by urinary protein:creatinine ratio (UPCR) ≥ 1.5 g/gor proteinuria ≥1.5 g/day on a 24-hour collection and ≤ 7 g/day by either measure

4. One or more of the following: positive antinuclear antibodies (ANA) ≥ 1:80 atscreening OR positive anti-dsDNA OR positive anti-Smith (anti-Sm)

5. Refractory LN defined as having received ≥ 2 prior therapies for LN (immunosuppressant and corticosteroid/or immunomodulatory agent, and corticosteroidat therapeutic range for at least 90 days), and had an inadequate response totherapy despite being on a therapeutic dose for ≥ 90 days

pMN-specific Inclusion Criteria:

1. Evidence of pMN by renal biopsy during screening or within 6 months before screening

2. Active renal disease at screening defined by spot UPCR ≥ 3.5 g/g or proteinuria ≥ 3.5 g/day on a 24-hour collection

3. Presence of primary membranous nephropathy autoantibodies

4. Refractory or intolerant to at least 1 induction therapy for pMN (immunosuppressantand corticosteroid or immunomodulatory agent and/corticosteroid) and defined as notachieving a complete remission after 180 days, or partial remission after 90 days

General Exclusion Criteria:

1. eGFR < 45 ml/min/1.73 m^2

2. Currently requiring renal dialysis or expected to require dialysis during the studyperiod

3. Previous solid organ or hematopoietic cell transplant or planned transplant withinstudy treatment period

4. Congenital or acquired immunodeficiency resulting in severe infection or thosereceiving chronic immunoglobulin replacement therapy

5. Liver disease or dysfunction, including cirrhosis and/or aspartate aminotransferase,alanine aminotransferase, or bilirubin ≥ 3 times the upper limit of normal

6. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthmarequiring daily oral steroids, resting hypoxemia (<92% oxygen saturation via pulseoximetry) on room air, or significant smoking history (i.e. >10 pack/year) withactive pulmonary disease

7. Bone marrow insufficiency unrelated to active underlying autoimmune disease withwhite blood cell count < 3,000/mm^3; hemoglobin levels < 9 gm/dL absolute neutrophilcount < 1500/mm^3; platelet count < 100,000/mm^3

8. Major cardiac disease, abnormalities, or interventions as defined by, but notlimited to:

9. Uncontrolled angina or unstable life-threatening arrhythmias

10. History of myocardial infarction within 12 weeks prior to the first dose ofNKX019

11. Any prior coronary artery bypass graft surgery

12. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF),significantly decreased ejection fraction (EF ≤ 40%), or severe cardiacinsufficiency.

13. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia)interval of > 480 msec

14. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2thrombotic or embolic events within 12 weeks prior to the first dose of NKX019

15. Uncontrolled hypertension (systolic BP > 160mmHg and/or diastolic BP > 90mmHg)despite therapy

16. Active bleeding disorders

17. Any overlapping autoimmune condition for which the condition or the treatment of thecondition may affect the study assessments or outcomes (eg, anti-GBM antibodyglomerulonephritis or any condition for additional immunosuppression is indicated);clinically significant conditions that could cause a secondary nephropathy (eg,infections, liver disease, tumors or drugs); or kidney biopsy-confirmed significantrenal disease other than disease under study (eg, diabetic nephropathy, hypertensivenephropathy). Overlapping conditions for which the condition or treatment is notexpected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoidarthritis) are not excluded

18. Pregnancy, breast feeding or, if of childbearing potential, not using adequatecontraceptive precautions

19. Current infection requiring active systemic anti-infective therapy or recent acuteinfection requiring systemic therapy within 30 days of planned LD

20. History of positive HIV antibody or test positive at screening, Hepatitis B or Cpositive at screening, active tuberculosis (TB) or latent TB requiring suppressivetherapy

21. Major surgery within 28 days prior to the first dose of NKX019 or any surgery fromwhich the participant has not recovered or has ongoing complications

22. Malignancy within 5 years of screening, with the exception of basal and squamouscell carcinomas treated by complete excision. Participants with cervical dysplasiathat is cervical intraepithelial neoplasia but have been treated with conization orloop electrosurgical excision procedure and have had a normal repeat Papanicolaoutest are allowed

23. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells

24. Central nervous system (CNS) comorbidity or any autoimmune disease with CNSinvolvement within 90 days prior to the first dose of NKX019 as well as active CNSlupus within 1 year prior to screening

25. Any other acute or chronic medical or psychiatric condition, or known laboratoryabnormality that, in the Investigator's opinion, is expected to interfere or impactstudy participation

26. Current participation in another interventional clinical trial a. Potential participants can be considered for enrollment after investigationalproduct washout period of 5 half-lives or 30 days, whichever is longer

27. Currently taking or known need for any of the medications prohibited in the studyprotocol

28. Known hypersensitivity or contraindications to the study treatment including LD; orother components such as human serum albumin or dimethyl sulfoxide

LN-specific Exclusion Criteria:

1. Known clinically active antiphospholipid antibody syndrome (APS); or high-risk profile