A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients with Autoimmune Disease

Cohort Legend: Cohort 1: Inflammatory Bowel Diseases - Crohn's Disease or Ulcerative Colitis, Cohort 2: Celiac Disease, Cohort 3: Ankylosing spondylitis or non-radiographic axial spondyloarthritis (nr-axSpA), Cohort 4: Multiple Sclerosis, Cohort 5: Scleroderma, Cohort 6: Systemic Sclerosis with pulmonary involvement, Cohort 7: Other Autoimmune Disease, Cohort 8: Apparent Evolving Autoimmune Disease, Cohort 9: Frozen Cryopreserved

Inclusion Criteria:

• Study cohorts 1,2,3,4,5,6,7,8.9: Known or suspected diagnosis, with subsequentdiagnostic confirmation, of one of the following cohorts associated with thefollowing autoimmune diseases:

• Inflammatory Bowel Diseases - Crohn's Disease or ulcerative colitis

• Celiac disease

• Ankylosing spondylitis or Non radiographic axial spondyloarthritis (nr-axSpA)

• Multiple sclerosis

• Scleroderma

• Systemic sclerosis with pulmonary involvement

• Other autoimmune disease (as agreed between Investigator and Sponsor)

• Apparent evolving autoimmune disease

• Frozen cryopreserved

• Age equal or greater than 18 years at time of informed consent.

• Ability to understand and willingness to sign an informed consent document wheninformed consent is required by an ethical review board.

• On disease-modifying treatments that are not known to be directly T cell toxic.

Such treatments are allowed and include:

• Non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, acetaminophen,celecoxib, indomethacin, diclofenac, etodolac, naproxen, meloxicam, sulindac,nabumetone amongst others.

• Tumor necrosis factor alpha (TNF-alpha) antagonists including infliximab (Remicade),adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi) and biosimilar drugs with the same generic name.

• Interleukin-12/23 antagonists including ustekinumab (Stelara) and risankizumab-rzaa (Skyrizi)

• Alpha-4-integrin antagonists including vedolizumab (Entyvio), natalizumab (Tysabri)

• Interleukin-17 inhibitors including secukinumab (Cosentyx), ixekizumab (Taltz)

• Recombinant interferon beta

• CD20 antagonists including rituximab (Rituxan), ocrelizumab (Ocrevus), ofatumumab (Kesimpta)

• Oral fumarates including dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam)

• Oral sphingosine 1-phosphate receptor (S1PR) modulators including fingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia), ponesimod (Ponvory)

• Oral glatiramer acetate (copolymer 1; Copaxone)

• Patient is an appropriate candidate for a procedure to obtain a biopsy, tissuesamples or biologic materials during a clinically indicated procedure where it isexpected that excess materials could be used for research OR

• In the opinion of the clinical investigator, a patient is an appropriate, low-riskcandidate for a research only procedure to obtain a biopsy, tissue samples orbiologic materials.

Exclusion Criteria:

• On treatment with drugs that are known to be T cell toxic and cannot be held for atleast 4 weeks or longer. The following treatments are not allowed except indesignated cohorts when approved by Sponsor:

• Glucocorticoids including prednisone, methylprednisolone (Solu-medrol), budesonide (Entocort), hydrocortisone (Solu-cortef), dexamethasone (Decadron), betamethasone (Betaject)

• Sulfasalazine (Azulfidine)

• Aminosalicylates including mesalamine/ mesalazine (Asacol, Pentasa).

• Thiopurines including azathioprine (Imuran) and 6-mercaptopurine (Purixan)

• Systemic JAK inhibitors including tofacitinib (Xeljanz), abrocitinib (Cibinqo),baricitinib (Olumiant), upadacitinib (Rinvoq)

• CD52 inhibitors including alemtuzumab (Campath)

• Methotrexate

• Cladribine

• Teriflunomide (Aubagio)

• Concurrent disease or condition that would make the patient inappropriate for studyparticipation, or any serious medical or psychiatric disorder that would interferewith the subject's safety.

• Dementia, altered mental status, or any psychiatric condition that would prohibitthe understanding or rendering of informed consent.

• Patients receiving research biopsy procedures will not have a history of serious orlife-threatening allergic reaction to local anesthetics (i.e., lidocaine,xylocaine), if local anesthetic is required for the procedure or to medications usedfor sedation during a procedure.

• Pregnant or nursing women are excluded because there may be unanticipated adverseevents and increased risk to both mother and fetus in the setting of localanesthetic or study procedures.

• Any other medical or psychiatric condition, which in the opinion of the patient'streating clinician, would make participation in this protocol unreasonably hazardousfor the patient.