Is NCT06733935 recruiting in Hackensack, NJ?

Yes, NCT06733935 is currently recruiting participants at its Hackensack, NJ location. This systemic sclerosis clinical trial is actively enrolling qualified participants.

How do I join the systemic sclerosis clinical trial in Hackensack?

To join this clinical trial in Hackensack, 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 Hackensack 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.

Systemic Sclerosis Clinical Trial in Hackensack, NJ

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

For participants taking corticosteroids, 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

eGFR as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥45 mL/min/1.73 m2 at screening SSc Inclusion Criteria:

Meets the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc

Meet criteria a and/or b: a. Severe skin involvement defined as mRSS ≥ 30 or active skin disease defined as mRSS ≥ 15 at screening and one or more of the following within the prior 6 months of screening: i. An increase in mRSS of ≥ 3 units ii. Involvement of 1 new body area with ≥ 2 mRSS units iii. 2 new body areas with ≥ 1 mRSS unit b. Moderate to severe Interstitial Lung Disease (ILD) defined by evidence of ILD on High-resolution computed tomography (HRCT) and FVC \< 70% of predicted or DLCO (hemoglobin or alveolar volume corrected) \< 70% of predicted or ILD on HRCT and progressive ILD meeting at least 2 of the following 3 criteria within the prior 6 months of screening: i. Worsening respiratory symptoms ii. Evidence of progression on HRCT, or iii. Evidence of absolute decline in FVC ≥ 5%

10 years or less since the first non-Raynaud's sign or symptom

Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF/mycophenolic acid, nintedanib, rituximab, or tocilizumab IIM Inclusion Criteria:

Diagnosis for IIM as per 2017 ACR/EULAR Classification Criteria

One positive myositis antibody

Activity defined as manual muscle testing (MMT-8) score \<136/150

Creatinine kinase or aldolase ≥ 1.5 x ULN and Clinician Global Assessment ≥ 2 cm with at least one of the following:

Evidence on magnetic resonance imaging (MRI) of active myositis within the last 6 months

Electromyography (EMG) with active myositis within the last 6 months

Muscle Biopsy of active myositis within last 6 months

Global extramuscular activity score ≥2 cm per Clinician global assessment (CGA) using a visual analog scale (VAS) (0-100 mm) Note: Participants with DM or ASyS may be eligible despite CK or aldolase \<1.5 × ULN, provided they have a Clinician Global Assessment ≥2 cm and meet at least one of criteria (a)-(d) above OR have a CDASI score of ≥20.

Inadequate response to treatment defined as ≥ 3 months failure (or intolerance) to at least 2 immunosuppressive therapies (including glucocorticoids) AAV:

Meets the 2022 ACR/EULAR classification criteria for Granulomatosis with Polyangiitis (GPA) (Robson 2022) or Microscopic Polyangiitis (MPA) (Suppiah 2022)

Relapsed or refractory AAV despite repeated treatment with immunosuppressive agents or requiring prolonged and/or repeated courses of unacceptable doses of glucocorticoids to maintain disease control

Positive test for anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening

Have at least one "major" item, or at least 3 other items, or at least 2 renal items on the BVAS version 3 RA Inclusion Criteria:

Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria

Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive

CRP \>3 mg/L

Inadequate response, defined as failure to achieve a clinically meaningful improvement (eg, ACR50 response or DAS28-low disease activity \[ie, DAS28 \>3.2\]) after at least 12 weeks of therapy with the following:

At least 1 conventional synthetic DMARD (csDMARD) (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) AND

Either of the following: i. At least 2 biologic (b) DMARDs (eg, TNF inhibitors, abatacept, anti-IL-6 or anti-IL-6R, rituximab) with distinct mechanisms of action (MoAs) OR ii. At least 1 bDMARD and at least 1 targeted synthetic DMARD (tsDMARD) (eg, JAK inhibitor) AND c. Have failed no more than 3 biologics or tsDMARDs with unique mechanisms of action

Minimum of 6 swollen joint counts (SJCs) and 6 tender joint counts (TJCs) according to joint assessment General

Exclusion Criteria

eGFR \< 45 ml/min/1.73m2

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 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

Participants with ILD with any of the following:

Requires supplemental oxygen therapy

FVC \<45% of predicted

Diffusing capacity of the lung (DLCO) corrected for alveolar volume (AV) or Hemoglobin (Hgb) ≤ 40% of predicted at screening (per Investigator or Sponsor judgement) i. If the participant has a historical FVC value within the last year that exceeds the 45% threshold, discuss with the Medical Monitor should the Screening FVC be \<45% predicted

Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \< 3,000/mm\^3; hemoglobin levels ≤ 9 g/dL; absolute neutrophil count (ANC) ≤ 1500/mm\^3; platelet count ≤ 100,000/mm\^3, and blood transfusion within 60 days prior to LD

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

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 test 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 evidence of CNS related autoimmune manifestations within 1 year prior to screening SSc Exclusion Criteria:

Moderate-to-severe Pulmonary arterial hypertension (PAH) on right heart catheterization requiring PAH specific treatment. Those participants with mild PAH (as defined by the 2022 ECS/ERS Guidelines, \[Humbert 2023\]) well controlled on therapy can be enrolled

Gastrointestinal (GI) dysmotility requiring total parenteral nutrition (TPN)

Renal crisis or Pericardial tamponade within 6 months prior to enrollment

Current gangrene of a digit IIM Exclusion Criteria:

Evidence of severe chronic proximal muscle involvement of upper or lower extremities, based on Magnetic Resonance Imaging (MRI) defined as:

≥15% fibro-fatty replacement in core muscle groups (including gluteus and vastus musculature), and/or

≥15% muscle atrophy in these regions Participants will also be excluded if the combined extent of fibro-fatty replacement and muscle atrophy exceeds 30% in aggregate

MMT-8 of ≤ 80

Findings of muscular inflammation or myopathy due to another cause, such as inclusion body myositis, cancer-associated myositis (myositis diagnosed within 2 years of cancer), amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic IIM rheumatologic disease (overlap myositis), except with Sjögren's syndrome

Generalized severe musculoskeletal or neuro-muscular conditions other than IIM

Immune-mediated necrotizing myopathy AAV Exclusion Criteria:

Alveolar hemorrhage requiring invasive pulmonary ventilation support

Required dialysis or plasma exchange within 12 weeks prior to screening

Any other known disease that may interfere with the assessments including eosinophilic GPA (Churg-Strauss), anti-glomerular basement membrane, systemic lupus erythematosus, IgA vasculitis (Henoch Schönlein), rheumatoid vasculitis, or cryoglobulinemic vasculitis

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 Hackensack?

Yes, this clinical trial (NCT06733935) has an active research site in Hackensack, NJ 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.

Systemic Sclerosis Treatment Options in Hackensack, NJ

If you're searching for systemic sclerosis treatment options in Hackensack, NJ, this clinical trial (NCT06733935) 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 Hackensack research site is actively enrolling participants for this clinical trial. You'll receive care from experienced systemic sclerosis 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 systemic sclerosis clinical trials near you to find additional studies recruiting in your area.

Systemic Sclerosis Clinical Trial in Hackensack, NJ

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