A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients with Autoimmune Disease
- Conditions
- Autoimmune DiseasesUlcerative ColitisMultiple SclerosisSclerodermaAnkylosing SpondylitisCeliac DiseaseNon-radiographic Axial Spondyloarthritis (nr-axSpA)Crohn's DiseaseBirdshot Chorioretinitis
- Registration Number
- NCT06587828
- Lead Sponsor
- TScan Therapeutics, Inc.
- Brief Summary
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/or 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.
The 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
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, 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identify peptide targets together with their associated TCRs in patients with autoimmune diseases under study. 3 Years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Arizona Arthritis & Rheumatology, PLLC
🇺🇸Phoenix, Arizona, United States
Inland Empire Gastroenterology
🇺🇸Murrieta, California, United States
Knowledge Research Center
🇺🇸Orange, California, United States
Cura Clinical Research
🇺🇸Sherman Oaks, California, United States
Neurostudies, LLC
🇺🇸Port Charlotte, Florida, United States
Rheumatology of Central Indiana
🇺🇸Muncie, Indiana, United States
University of Kentucky Research Foundation
🇺🇸Lexington, Kentucky, United States
Gastroenterology Group of Rochester
🇺🇸Rochester, New York, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
Digestive Disease Specialists, Inc
🇺🇸Oklahoma City, Oklahoma, United States
Scroll for more (8 remaining)Arizona Arthritis & Rheumatology, PLLC🇺🇸Phoenix, Arizona, United StatesHani Rashid, DOContact