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

Launched by TSCAN THERAPEUTICS, INC. · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to better understand autoimmune diseases, such as Crohn's disease, ulcerative colitis, multiple sclerosis, and others, by examining tissues from patients experiencing inflammation. Researchers want to collect samples from these inflamed areas to identify the specific T cells (a type of immune cell) that are active and involved in the disease. By isolating and analyzing these T cells, the goal is to find new targets to develop therapies that could help manage autoimmune diseases more effectively.

To participate, you need to be at least 18 years old and have a confirmed diagnosis of one of the autoimmune conditions listed, such as Crohn's disease or multiple sclerosis. Eligible participants will have a biopsy procedure to collect tissue samples, which is a routine process where a small piece of tissue is taken for study. The trial is currently recruiting participants, and it’s important to note that certain treatments that might harm T cells are not allowed. Overall, this study aims to discover new ways to treat autoimmune diseases by better understanding the immune response in affected tissues.

Gender

ALL

Eligibility criteria

• • 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 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.
• Exclusion Criteria:
• * 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.