Is NCT06557265 recruiting in Atlanta, GA?

Yes, NCT06557265 is currently recruiting participants at its Atlanta, GA location. This lupus nephritis clinical trial is actively enrolling qualified participants.

How do I join the lupus nephritis clinical trial in Atlanta?

To join this clinical trial in Atlanta, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Atlanta clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lupus Nephritis Clinical Trial in Atlanta, GA

Who Can Participate

Inclusion Criteria

Age ≥18 and ≤75

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

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

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

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

For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening LN-specific Inclusion Criteria:

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

Active biopsy proven lupus nephritis Class III or Class IV without Class V overlap using the 2018 International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria as evidenced on kidney biopsy during consent or within 6 months before screening. The biopsy must have at least mild to moderate activity score and no more than moderate chronicity index per NIH indices

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

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

Refractory LN defined as having received ≥ 2 prior therapies for LN (immunosuppressant and corticosteroid/or immunomodulatory agent, and corticosteroid at therapeutic range for at least 90 days), and had an inadequate response to therapy despite being on a therapeutic dose for ≥ 90 days pMN-specific Inclusion Criteria:

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

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

Presence of primary membranous nephropathy autoantibodies

Refractory or intolerant to at least 1 induction therapy for pMN (immunosuppressant and corticosteroid or immunomodulatory agent and/corticosteroid) and defined as not achieving a complete remission after 180 days, or partial remission after 90 days General

Exclusion Criteria

eGFR \< 45 ml/min/1.73 m\^2

Currently requiring renal dialysis or expected to require dialysis during the study period

Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period

Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy

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

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

Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \< 3,000/mm\^3; hemoglobin levels \< 9 gm/dL absolute neutrophil count \< 1500/mm\^3; platelet count \< 100,000/mm\^3

Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:

Uncontrolled angina or unstable life-threatening arrhythmias

History of myocardial infarction within 12 weeks prior to the first dose of NKX019

Any prior coronary artery bypass graft surgery

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

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

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

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

Active bleeding disorders

Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis 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 significant renal disease other than disease under study (eg, diabetic nephropathy, hypertensive nephropathy). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoid arthritis) are not excluded

Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions

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

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

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

Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants 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

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

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

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

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

Currently taking or known need for any of the medications prohibited in the study protocol

Known hypersensitivity or contraindications to the study treatment including LD; or other 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT06557265) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lupus Nephritis Treatment Options in Atlanta, GA

If you're searching for lupus nephritis treatment options in Atlanta, GA, this clinical trial (NCT06557265) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this clinical trial. You'll receive care from experienced lupus nephritis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lupus nephritis clinical trials near you to find additional studies recruiting in your area.

Lupus Nephritis Clinical Trial in Atlanta, GA

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