A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)

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

This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Systemic Sclerosis; Idiopathic Inflammatory Myopathies; Antineutrophil Cytoplasmic Antibody-Associated Vasculitis
• Intervention / Treatment: Drug: NKX019; Drug: Cyclophosphamide; Drug: Fludarabine

Detailed Description

Dose escalation of NKX019 will utilize a "3+3" design to determine the recommended dose(s) for expansion for enrolling additional participants across indications. The study will evaluate safety and tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity in participants with autoimmune diseases. Participants will receive a cycle consisting of lymphodepletion with fludarabine and cyclophosphamide (Flu/Cy) followed by three doses of NKX019. Participants who are cytopenic may receive a modified lymphodepletion regimen of Cy alone.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nkarta Central Contact; Phone Number: Only use email; Email: clinicaltrials@nkartatx.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
• Puerto Rico
  • Manati, Puerto Rico, 00674
    • Recruiting
    • Nkarta Investigational Site
    • Contact: Nkarta Central Contact
• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
  • Florida
    • Miami, Florida, United States, 33133
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
    • Plantation, Florida, United States, 33317
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
    • Summit, New Jersey, United States, 07302
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
  • New York
    • New York, New York, United States, 10007
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
    • Syracuse, New York, United States, 13202
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
  • Texas
    • Dallas, Texas, United States, 75201
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact
    • Houston, Texas, United States, 77002
      • Recruiting
      • Nkarta Investigational Site
      • Contact: Nkarta Central Contact

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

General Inclusion Criteria:

1. Age ≥18 and ≤75
2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements
3. 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
4. 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
5. For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening
6. 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:

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

2. 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%

3. 10 years or less since the first non-Raynaud's sign or symptom
4. Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF/mycophenolic acid, nintedanib, rituximab, or tocilizumab

IIM Inclusion Criteria:

1. Diagnosis for IIM as per 2017 ACR/EULAR Classification Criteria
2. One positive myositis antibody
3. Activity defined as manual muscle testing (MMT-8) score <136/150

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

   1. Evidence on magnetic resonance imaging (MRI) of active myositis within the last 6 months
   2. Electromyography (EMG) with active myositis within the last 6 months
   3. Muscle Biopsy of active myositis within last 6 months
   4. 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.

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

AAV:

1. Meets the 2022 ACR/EULAR classification criteria for Granulomatosis with Polyangiitis (GPA) (Robson 2022) or Microscopic Polyangiitis (MPA) (Suppiah 2022)
2. 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
3. Positive test for anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening
4. 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:

1. Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria
2. Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive
3. CRP >3 mg/L

4. 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:

   1. At least 1 conventional synthetic DMARD (csDMARD) (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) AND
   2. 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

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

General Exclusion Criteria:

1. eGFR < 45 ml/min/1.73m2
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 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. Participants with ILD with any of the following:

   1. Requires supplemental oxygen therapy
   2. FVC <45% of predicted
   3. 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

8. 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

9. 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
10. Active bleeding disorders
11. 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
12. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions
13. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD
14. History of positive HIV test at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy
15. 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
16. 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
17. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells
18. 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:

1. 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
2. Gastrointestinal (GI) dysmotility requiring total parenteral nutrition (TPN)
3. Renal crisis or Pericardial tamponade within 6 months prior to enrollment
4. Current gangrene of a digit

IIM Exclusion Criteria:

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

   1. ≥15% fibro-fatty replacement in core muscle groups (including gluteus and vastus musculature), and/or
   2. ≥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
2. MMT-8 of ≤ 80
3. 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
4. Generalized severe musculoskeletal or neuro-muscular conditions other than IIM
5. Immune-mediated necrotizing myopathy

AAV Exclusion Criteria:

1. Alveolar hemorrhage requiring invasive pulmonary ventilation support
2. Required dialysis or plasma exchange within 12 weeks prior to screening
3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NKX019 - CAR NK cell therapy; Phase 1/2: NKX019 plus fludarabine and cyclophosphamide	Drug: NKX019; NKX019 is an investigational allogeneic CD19-Directed CAR NK; Drug: Cyclophosphamide; Lymphodepletion; Drug: Fludarabine; Lymphodepletion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability]	Incidence of DLTs will be evaluated	The first 28 days after the first NKX019 dose
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence and severity of treatment-emergent adverse events will be evaluated	From the first administration of NKX019 until the last administration of any study treatment + 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameter: maximum concentration (Cmax)		Up to 2 years after NKX019 infusion
Pharmacokinetics parameter: Time-to-maximum concentration (Tmax)		Up to 2 years after NKX019 infusion
Pharmacokinetics parameter: Area under the curve (AUC)		Up to 2 years after NKX019 infusion
Pharmacokinetics parameter: Half-life (t1/2)		Up to 2 years after NKX019 infusion
Duration of persistence of NKX019 in peripheral blood		Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)	Change from baseline in % predicted forced vital capacity (FVC) over time	Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)	Change from baseline in modified Rodnan skin score (mRSS)	Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)	Proportion of participants achieving revised Composite Response Index (rCRISS) 25, 50 and 70 at 3, 6, and 12 months compared to baseline	Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)	Change from baseline modified EULAR (European Alliance of Associations for Rheumatology) Scleroderma	Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)	Trials and Research Activity Index (EUSTAR AI) over time	Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)	Change from baseline University of California Los Angeles Gastrointestinal Tract (UCLA GIT) 2.0 assessments over time	Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)	Change from baseline in manual muscle testing (MMT) over time	Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)	Change from baseline and normalization of muscle enzymes over time	Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)	Proportion of participants achieving a mild, moderate, or major (20, 40, 60 points) clinical response by Total Improvement Score (TIS) at 3, 6, and 12 months (including assessment of change from baseline in TIS components)	Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)	Proportion of participants achieving Birmingham Vasculitis Activity Score (BVAS) remission at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)	Change from baseline BVAS over time	Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)	Proportion of participants achieving clinical remission Off Therapy (CROffT) at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)	Proportion of participants achieving clinical remission On Therapy (CROnT) at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
Assess humoral and cellular immunogenicity over time with validated methods that include: a cell-based flow cytometry assay for anti-NKX019 antibodies and an antigen bead-assay using flow cytometry for detection of anti-HLA antibodies		Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)	Change from baseline % predicted CO (DLCO) corrected for hemoglobin [and as appropriate alveolar volume (AV)] over time	Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)	Time to improvement in FVC by ≥5% or ≥10%	Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)	Proportion of participants with improvement in FVC by ≥5% or ≥10%	Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)	Time to ILD progression	Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)	Proportion of participants with ILD progression	Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)	Change from baseline Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score over time for those with cutaneous manifestations	Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)	Proportion of participants achieving low disease activity state (LDAS) at 3, 6, and 12 months, change from baseline CRP over time	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Change from baseline in Disease Activity Score for 28 Joints - CRP (DAS28-CRP) over time	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Proportion of participants achieving DAS28-CRP remission at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Proportion of participants achieving DAS28-CRP low disease activity at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Proportion of participants achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 response at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Change from baseline in HAQ-DI over time	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Change from baseline in participant assessment of pain over time	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Change from baseline in the clinician global assessment of disease activity over time	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Change from baseline in the patient global assessment of disease activity over time	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Proportion of participants achieving Clinical Disease Activity Index (CDAI) remission at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Proportion of participants achieving CDAI low disease activity at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Proportion of participants achieving Simplified Disease Activity Index (SDAI) remission at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)	Proportion of participants achieving SDAI low disease activity at 3, 6, and 12 months	Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies	Proportion of participants requiring rescue therapy (SSc, IIM, AAV, RA) over time	Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies	Proportion of participants who are steroid free (IIM, AAV, RA) over time	Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies	Cumulative corticosteroid dose (IIM, AAV, RA) over time	Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies	Proportion of participants receiving ≤ 5 mg daily prednisone (or equivalent) (IIM, AAV, RA) over time	Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies	Proportion of participants receiving ≤ 7.5 mg daily prednisone (or equivalent) (IIM, AAV, RA) over time	Up to 2 years after NKX019 infusion

Collaborators and Investigators

• Sponsor: Nkarta, Inc.
• Investigators: Study Director: Nkarta Study Director, Nkarta, Inc.

Publications and helpful links

Helpful Links

• The Ntrust-2 Study for Autoimmune Diseases

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cell Therapy; Immunotherapy; Rheumatoid Arthritis; Myositis; Allogeneic; CD19; Systemic Sclerosis; AAV; CAR; IL-15; Idiopathic Inflammatory Myopathies; Scleroderma; Adoptive cell therapy; Natural Killer Cells; Interleukin-15; NKX019; Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis; Ntrust-2
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Neuromuscular Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin Diseases, Vascular; Vasculitis; Systemic Vasculitis; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Arthritis, Rheumatoid; Myositis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Organic Chemicals; Hydrocarbons; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclophosphamide; fludarabine
• Other Study ID Numbers: Ntrust-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No