RECRUITING

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

Conditions

Lupus Nephritis Primary Membranous Nephropathy CD19 CAR Allogeneic NKX019 Interleukin 15 Cell Therapy Immunotherapy Adoptive cell therapy Ntrust-1 LN pMN

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, multi-center, non-randomized, Phase 1/2 study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with active lupus nephritis (LN) or primary membranous nephropathy (pMN).

Official Title

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

Quick Facts

Study Start:2024-06-13

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06557265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 under study, the prednisone (or equivalent) dose must be ≤40 mg/day at 6 weeks prior to Screening 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	1. eGFR \< 45 ml/min/1.73 m\^2 2. Currently requiring renal dialysis or expected to require dialysis during the study period 3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period 4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving 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 asthma requiring daily oral steroids, resting hypoxemia (\<92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \>10 pack/year) with active pulmonary disease 7. White blood cell count \< 3,000/mm\^3; hemoglobin levels \< 9 gm/dL absolute neutrophil count \< 2,000/mm\^3; platelet count \< 100,000/mm\^3 8. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to: 1. Uncontrolled angina or unstable life-threatening arrhythmias 2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019 3. Any prior coronary artery bypass graft surgery 4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency. 5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \> 480 msec 6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019 7. Uncontrolled hypertension (systolic blood pressure \> 160mmHg and diastolic \> 90mmHg) despite therapy 9. Active bleeding disorders 10. Any overlapping autoimmune condition for which the condition itself or the treatment of that condition may affect the study assessments or outcomes; clinically significant conditions that could cause a secondary nephropathy; or kidney biopsy-confirmed significant renal disease other than disease under study 11. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions 12. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD 13. History of positive HIV antibody or test positive at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy 14. Major surgery within 28 days prior to the first dose of NKX019 15. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed 16. Prior cellular therapy 17. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as active CNS lupus within 1 year prior to screening 18. Any other acute or chronic medical or psychiatric condition, or known laboratory abnormality that, in the Investigator's opinion, is expected to interfere or impact study participation 19. 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. 20. Currently taking or known need for any of the medications prohibited in the study protocol 21. Known hypersensitivity or contraindications to the study treatment including LD; or other components such as human serum albumin or dimethyl sulfoxide

Inclusion Criteria

Exclusion 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 under study, the prednisone (or equivalent) dose must be ≤40 mg/day at 6 weeks prior to Screening 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

1. eGFR \< 45 ml/min/1.73 m\^2
2. Currently requiring renal dialysis or expected to require dialysis during the study period
3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period
4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving 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 asthma requiring daily oral steroids, resting hypoxemia (\<92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \>10 pack/year) with active pulmonary disease
7. White blood cell count \< 3,000/mm\^3; hemoglobin levels \< 9 gm/dL absolute neutrophil count \< 2,000/mm\^3; platelet count \< 100,000/mm\^3
8. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:
1. Uncontrolled angina or unstable life-threatening arrhythmias
2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019
3. Any prior coronary artery bypass graft surgery
4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency.
5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \> 480 msec
6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019
7. Uncontrolled hypertension (systolic blood pressure \> 160mmHg and diastolic \> 90mmHg) despite therapy
9. Active bleeding disorders
10. Any overlapping autoimmune condition for which the condition itself or the treatment of that condition may affect the study assessments or outcomes; clinically significant conditions that could cause a secondary nephropathy; or kidney biopsy-confirmed significant renal disease other than disease under study
11. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions
12. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD
13. History of positive HIV antibody or test positive at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy
14. Major surgery within 28 days prior to the first dose of NKX019
15. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed
16. Prior cellular therapy
17. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as active CNS lupus within 1 year prior to screening
18. Any other acute or chronic medical or psychiatric condition, or known laboratory abnormality that, in the Investigator's opinion, is expected to interfere or impact study participation
19. 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.
20. Currently taking or known need for any of the medications prohibited in the study protocol
21. Known hypersensitivity or contraindications to the study treatment including LD; or other components such as human serum albumin or dimethyl sulfoxide

Contacts and Locations

Study Contact

Nkarta Central Contact

CONTACT

Only Use Email

clinicaltrials@nkartatx.com

Principal Investigator

Nkarta Study Director

STUDY_DIRECTOR

Nkarta, Inc.

Study Locations (Sites)

Nkarta Investigational Site

Little Rock, Arkansas, 72201

United States

Nkarta Investigational Site

Gainesville, Florida, 32610

United States

Nkarta Investigational Site

Miami, Florida, 33133

United States

Nkarta Investigational Site

Plantation, Florida, 33317

United States

Nkarta Investigational Site

Atlanta, Georgia, 30303

United States

Nkarta Investigational Site

Chicago, Illinois, 60612

United States

Nkarta Investigational Site

New Orleans, Louisiana, 70112

United States

Nkarta Investigational Site

Worcester, Massachusetts, 01608

United States

Nkarta Investigational Site

Ann Arbor, Michigan, 48109

United States

Nkarta Investigational Site

New York, New York, 10007

United States

Nkarta Investigational Site

Stony Brook, New York, 11794

United States

Nkarta Investigational Site

Dallas, Texas, 75201

United States

Nkarta Investigational Site

Houston, Texas, 77002

United States

Collaborators and Investigators

Sponsor: Nkarta, Inc.

Nkarta Study Director, STUDY_DIRECTOR, Nkarta, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-13

Study Completion Date2027-04

Study Record Updates

Study Start Date2024-06-13

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

CD19
CAR
Allogeneic
NKX019
Interleukin 15
Cell Therapy
Immunotherapy
Adoptive cell therapy
Lupus Nephritis
Ntrust-1
LN
Primary Membranous Nephropathy
pMN

Additional Relevant MeSH Terms

Lupus Nephritis
Primary Membranous Nephropathy