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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTScan Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Inflammatory Bowel Diseases - Crohn's Disease or ulcerative colitis

Celiac disease

Ankylosing spondylitis or Non radiographic axial spondyloarthritis (nr-axSpA)

Multiple sclerosis

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Companion blood samples with procedure

Treatment groups

300 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators