Biospecimen Collection Study for Autoimmune Diseases
This study is looking for people with autoimmune diseases like ulcerative colitis, multiple sclerosis, scleroderma, and ankylosing spondylitis. The goal is to understand how certain immune cells, called T cells, contribute to these diseases. Researchers will collect blood samples when you have a procedure to get tissue or fluid. By studying these samples, they hope to identify specific targets that T cells react to in your body. This information could help develop new ways to treat autoimmune diseases. The study aims to enroll 300 participants.
- Study design
- This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 300 participants.
- What's involved
- You would provide a blood sample around the time you have a procedure to obtain tissue or fluid.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study aims to identify targets within 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06587828
A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients With Autoimmune Disease
Recruiting
Not specifiedAges 18+ObservationalTScan Therapeutics, Inc.
~300 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:Companion blood samples with procedure
At a glance
Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identify peptide targets together with their associated TCRs in patients with autoimmune diseases under study.
Measured over 3 Years
Conditions
Where it's being run
12 sites across 9 statesRhode Island3
California2
Illinois1
Kentucky1
Massachusetts1
Pennsylvania1
South Carolina1
Texas1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
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 when informed consent is required by an ethical review board.
On disease-modifying treatments that are not known to be directly T cell toxic.
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, tissue samples or biologic materials during a clinically indicated procedure where it is expected that excess materials could be used for research OR
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.
Exclusion
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:
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 study participation, or any serious medical or psychiatric disorder that would interfere with the subject's safety.
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
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.
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.
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.
What this trial measures
- Identify peptide targets together with their associated TCRs in patients with autoimmune diseases under study.3 Years