[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crohnamp39s-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crohnamp39s-disease":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100561258","a-biospecimen-collection-study-to-identify-the-targets-of-disease-reactive-t-cells-in-patients-with-autoimmune-disease-100561258",false,"NCT06587828","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\n\nInclusion Criteria:\n\n* Study cohorts 1,2,3,4,5,6,7,8.9: Known or suspected diagnosis, with subsequent diagnostic confirmation, of one of the following cohorts associated with the following autoimmune diseases:\n* Inflammatory Bowel Diseases - Crohn's Disease or ulcerative colitis\n* Celiac disease\n* Ankylosing spondylitis or Non radiographic axial spondyloarthritis (nr-axSpA)\n* Multiple sclerosis\n* Scleroderma\n* Systemic sclerosis with pulmonary involvement\n* Other autoimmune disease (as agreed between Investigator and Sponsor)\n* Apparent evolving autoimmune disease\n* Frozen cryopreserved\n* Age equal or greater than 18 years at time of informed consent.\n* Ability to understand and willingness to sign an informed consent document when informed consent is required by an ethical review board.\n* On disease-modifying treatments that are not known to be directly T cell toxic.\n\nSuch treatments are allowed and include:\n\n* Non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, acetaminophen, celecoxib, indomethacin, diclofenac, etodolac, naproxen, meloxicam, sulindac, nabumetone amongst others.\n* 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.\n* Interleukin-12\u002F23 antagonists including ustekinumab (Stelara) and risankizumab-rzaa (Skyrizi)\n* Alpha-4-integrin antagonists including vedolizumab (Entyvio), natalizumab (Tysabri)\n* Interleukin-17 inhibitors including secukinumab (Cosentyx), ixekizumab (Taltz)\n* Recombinant interferon beta\n* CD20 antagonists including rituximab (Rituxan), ocrelizumab (Ocrevus), ofatumumab (Kesimpta)\n* Oral fumarates including dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam)\n* Oral sphingosine 1-phosphate receptor (S1PR) modulators including fingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia), ponesimod (Ponvory)\n* Oral glatiramer acetate (copolymer 1; Copaxone)\n* Patient is an appropriate candidate for a procedure to obtain a biopsy, tissue samples or biologic materials during a clinically indicated procedure where it is expected that excess materials could be used for research OR\n* In the opinion of the clinical investigator, a patient is an appropriate, low-risk candidate for a research only procedure to obtain a biopsy, tissue samples or biologic materials.\n\nExclusion Criteria:\n\n* On treatment with drugs that are known to be T cell toxic and cannot be held for at least 4 weeks or longer. The following treatments are not allowed except in designated cohorts when approved by Sponsor:\n* Glucocorticoids including prednisone, methylprednisolone (Solu-medrol), budesonide (Entocort), hydrocortisone (Solu-cortef), dexamethasone (Decadron), betamethasone (Betaject)\n* Sulfasalazine (Azulfidine)\n* Aminosalicylates including mesalamine\u002F mesalazine (Asacol, Pentasa).\n* Thiopurines including azathioprine (Imuran) and 6-mercaptopurine (Purixan)\n* Systemic JAK inhibitors including tofacitinib (Xeljanz), abrocitinib (Cibinqo), baricitinib (Olumiant), upadacitinib (Rinvoq)\n* CD52 inhibitors including alemtuzumab (Campath)\n* Methotrexate\n* Cladribine\n* Teriflunomide (Aubagio)\n* Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with the subject's safety.\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n* Patients receiving research biopsy procedures will not have a history of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine), if local anesthetic is required for the procedure or to medications used for sedation during a procedure.\n* Pregnant or nursing women are excluded because there may be unanticipated adverse events and increased risk to both mother and fetus in the setting of local anesthetic or study procedures.\n* Any other medical or psychiatric condition, which in the opinion of the patient's treating clinician, would make participation in this protocol unreasonably hazardous for the patient.","ALL","18 Years",{"count":18,"type":19},300,"ESTIMATED","OBSERVATIONAL","The most clinically meaningful way to discover new targets of T cells in autoimmune diseases is to study the tissues of patients with active autoimmune disease mediated organ inflammation. These tissues contain both cytotoxic and helper T cells that are driving their disease, and these T cells are being guided by TCRs that recognize tissue-specific targets. By collecting tissue when a patient has active inflammation, it is possible to determine which T cells are activated and undergoing clonal expansion in the patient's diseased organ. TScan has developed a genome-wide, high-throughput technology to determine the natural, physiological target of any TCR (Kula, 2019). The goal of this study is to isolate T cells from inflamed tissues and matched blood samples and\u002For matched normal tissues (for patients with inflammatory bowel diseases). T cell clones that are expanded in diseased tissues relative to blood or normal tissues will be selected and the targets of their TCRs will be defined using TScan's genome-wide, high-throughput target ID technology.\n\nThe goal of this study is to discover a collection of peptide targets, along with their associated TCRs to be developed as new tolerogenic therapies for patients with autoimmune diseases.",[23,24,25,26,27,28,29,30,31],"Autoimmune Diseases","Ulcerative Colitis","Multiple Sclerosis","Scleroderma","Ankylosing Spondylitis","Celiac Disease","Non-radiographic Axial Spondyloarthritis (Nr-axSpA)","Crohn&Amp;#39;s Disease","Birdshot Chorioretinitis",[23,25,33,27,26,34,35,36,31],"Systemic Sclerosis","Inflammatory Bowel Disease","Crohn's Disease","Non-radiographic axial spondyloarthritis (nr-axSpA)","RECRUITING","2025-11-21",{"date":40,"type":41},"2025-11-24","ACTUAL",{"date":43,"type":41},"2023-01-03",{"date":45,"type":19},"2027-01",{"name":47,"class":48},"TScan Therapeutics, Inc.","INDUSTRY",12]