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

General Inclusion Criteria:

1. Age ≥18 and ≤70

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

3. For participants taking chronic corticosteroids for management of the disease understudy, the prednisone (or equivalent) dose must be ≤40 mg/day at 6 weeks prior toScreening and stable for ≥ 14 days before start of Screening

4. Negative SARS-CoV-2 test

5. For subjects on immunosuppressives or immunomodulators (other than corticosteroids),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 with or without Class Vusing the 2018 International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria (Bajema 2018) as evidenced on kidney biopsy during screening orwithin 6 months before screening. For subjects with primarily Class III or Class IVLN, the biopsy must have at least mild to moderate activity score (≥4/24) and nomore than moderate chronicity index (≤ 6/12) 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. Positive antinuclear antibodies (ANA) ≥ 1:80 OR anti-dsDNA OR 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. Positive anti-PLA2R antibodies

4. Refractory or intolerant to at least one induction therapy for pMN (immunosuppressant and corticosteroid or immunomodulatory agent and/corticosteroid)and defined as not achieving a complete remission after 180 days, or partialremission 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. White blood cell count < 3,000/mm^3; hemoglobin levels < 9 gm/dL absolute neutrophilcount < 2,000/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 blood pressure > 160mmHg and diastolic > 90mmHg) despite therapy

16. Active bleeding disorders

17. Any overlapping autoimmune condition for which the condition itself or the treatmentof that condition may affect the study assessments or outcomes; clinicallysignificant conditions that could cause a secondary nephropathy; or kidneybiopsy-confirmed significant renal disease other than disease under study

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

22. Malignancy within 5 years of screening, with the exception of basal and squamouscell carcinomas treated by complete excision. Subjects with cervical dysplasia thatis cervical intraepithelial neoplasia but have been treated with conization or loopelectrosurgical excision procedure and have had a normal repeat Papanicolaou testare allowed

23. Prior cellular therapy

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. Disease-modifying therapies for disease under study or investigational agents within 14 days or 5 half-lives of the drug (whichever is shorter), prior to LD. a. For those subjects on B-cell-depleting or -modulating drugs (ie, rituximab,belimumab), the subject must have received first dose ≥ 6 months prior to LD

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