RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-03
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06587828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * Inflammatory Bowel Diseases - Crohn's Disease or ulcerative colitis
  3. * Celiac disease
  4. * Ankylosing spondylitis or Non radiographic axial spondyloarthritis (nr-axSpA)
  5. * Multiple sclerosis
  6. * Scleroderma
  7. * Systemic sclerosis with pulmonary involvement
  8. * Other autoimmune disease (as agreed between Investigator and Sponsor)
  9. * Apparent evolving autoimmune disease
  10. * Frozen cryopreserved
  11. * Age equal or greater than 18 years at time of informed consent.
  12. * Ability to understand and willingness to sign an informed consent document when informed consent is required by an ethical review board.
  13. * On disease-modifying treatments that are not known to be directly T cell toxic.
  14. * Non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, acetaminophen, celecoxib, indomethacin, diclofenac, etodolac, naproxen, meloxicam, sulindac, nabumetone amongst others.
  15. * 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.
  16. * Interleukin-12/23 antagonists including ustekinumab (Stelara) and risankizumab-rzaa (Skyrizi)
  17. * Alpha-4-integrin antagonists including vedolizumab (Entyvio), natalizumab (Tysabri)
  18. * Interleukin-17 inhibitors including secukinumab (Cosentyx), ixekizumab (Taltz)
  19. * Recombinant interferon beta
  20. * CD20 antagonists including rituximab (Rituxan), ocrelizumab (Ocrevus), ofatumumab (Kesimpta)
  21. * Oral fumarates including dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam)
  22. * Oral sphingosine 1-phosphate receptor (S1PR) modulators including fingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia), ponesimod (Ponvory)
  23. * Oral glatiramer acetate (copolymer 1; Copaxone)
  24. * 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
  25. * 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.
  1. * 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:
  2. * Glucocorticoids including prednisone, methylprednisolone (Solu-medrol), budesonide (Entocort), hydrocortisone (Solu-cortef), dexamethasone (Decadron), betamethasone (Betaject)
  3. * Sulfasalazine (Azulfidine)
  4. * Aminosalicylates including mesalamine/ mesalazine (Asacol, Pentasa).
  5. * Thiopurines including azathioprine (Imuran) and 6-mercaptopurine (Purixan)
  6. * Systemic JAK inhibitors including tofacitinib (Xeljanz), abrocitinib (Cibinqo), baricitinib (Olumiant), upadacitinib (Rinvoq)
  7. * CD52 inhibitors including alemtuzumab (Campath)
  8. * Methotrexate
  9. * Cladribine
  10. * Teriflunomide (Aubagio)
  11. * 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.
  12. * Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  13. * 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.
  14. * 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.
  15. * 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.

Contacts and Locations

Study Contact

Laurie Barefoot
CONTACT
857-399-9930
Lbarefoot@tscan.com
Shrikanta Chattopadhyay
CONTACT
Schattopadhyay@tscan.com

Study Locations (Sites)

Arizona Arthritis & Rheumatology, PLLC
Phoenix, Arizona, 85032
United States
Inland Empire Gastroenterology
Murrieta, California, 92562
United States
Knowledge Research Center
Orange, California, 92868
United States
Cura Clinical Research
Sherman Oaks, California, 91403
United States
Neurostudies, LLC
Port Charlotte, Florida, 33952
United States
Rheumatology of Central Indiana
Muncie, Indiana, 47304
United States
University of Kentucky Research Foundation
Lexington, Kentucky, 40536
United States
Gastroenterology Group of Rochester
Rochester, New York, 14618
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
United States
Digestive Disease Specialists, Inc
Oklahoma City, Oklahoma, 73112
United States
Susquehanna Research Group
Harrisburg, Pennsylvania, 17110
United States
Nexus Research
Cranston, Rhode Island, 02920
United States
Nexus Research
Cranston, Rhode Island, 02920
United States
Nexus Research
Cranston, Rhode Island, 02920
United States
Nexus Research
Cranston, Rhode Island, 02920
United States
Nexus Research
Cranston, Rhode Island, 02920
United States
University Gastroenterology
Providence, Rhode Island, 02904
United States
Palmetto Gastroenterology Clinical Research, LLC
Summerville, South Carolina, 29486
United States
Advanced Gastroenterology
Union City, Tennessee, 38261
United States
Novel Research
Bellaire, Texas, 77401
United States
GI Research Partners, LLC
Chesterfield, Virginia, 23236
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: TScan Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-03
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-01-03
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Autoimmune Diseases
  • Multiple Sclerosis
  • Systemic Sclerosis
  • Ankylosing Spondylitis
  • Scleroderma
  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Non-radiographic axial spondyloarthritis (nr-axSpA)
  • Birdshot Chorioretinitis

Additional Relevant MeSH Terms

  • Autoimmune Diseases
  • Ulcerative Colitis
  • Multiple Sclerosis
  • Scleroderma
  • Ankylosing Spondylitis
  • Celiac Disease
  • Non-radiographic Axial Spondyloarthritis (nr-axSpA)
  • Crohn's Disease
  • Birdshot Chorioretinitis