Actively Recruiting

Age: 18Years +
All Genders
NCT06587828

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

Led by TScan Therapeutics, Inc. · Updated on 2025-11-24

300

Participants Needed

12

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of informed consent
  • Known or suspected diagnosis of autoimmune diseases including Crohn's disease, ulcerative colitis, celiac disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, multiple sclerosis, scleroderma, systemic sclerosis with pulmonary involvement, other autoimmune diseases, or apparent evolving autoimmune disease
  • Receiving disease-modifying treatments not known to be directly toxic to T cells
  • Candidate for biopsy or tissue sample collection during a clinically indicated or research procedure
  • Ability to understand and willingness to sign informed consent when required
Not Eligible

You will not qualify if you...

  • Treatment with drugs known to be T cell toxic that cannot be stopped for 4 weeks or longer, including glucocorticoids, sulfasalazine, aminosalicylates, thiopurines, systemic JAK inhibitors, CD52 inhibitors, methotrexate, cladribine, or teriflunomide
  • Any serious medical or psychiatric condition that could interfere with safety or consent
  • Dementia, altered mental status, or psychiatric conditions preventing informed consent
  • History of severe allergic reaction to local anesthetics or sedation medications if required for biopsy procedures
  • Pregnant or nursing women
  • Any other condition judged by the treating clinician to make study participation unreasonably hazardous

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 12 locations

1

Knowledge Research Center

Orange, California, United States, 92868

Actively Recruiting

2

Cura Clinical Research

Sherman Oaks, California, United States, 91403

Actively Recruiting

3

Arnold Arthritis & Rheumatology

Skokie, Illinois, United States, 60076

Actively Recruiting

4

University of Kentucky Research Foundation

Lexington, Kentucky, United States, 40536

Actively Recruiting

5

Massachusetts Eye Research and Surgery Institution (MERSI)

Waltham, Massachusetts, United States, 02451

Actively Recruiting

6

Susquehanna Research Group

Harrisburg, Pennsylvania, United States, 17110

Actively Recruiting

7

Nexus Research

Cranston, Rhode Island, United States, 02920

Actively Recruiting

8

Nexus Research

Cranston, Rhode Island, United States, 02920

Actively Recruiting

9

RI Rheumatology

Cranston, Rhode Island, United States, 02920

Actively Recruiting

10

Palmetto Gastroenterology Clinical Research, LLC

Summerville, South Carolina, United States, 29486

Actively Recruiting

11

Novel Research

Bellaire, Texas, United States, 77401

Actively Recruiting

12

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Completed

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Research Team

L

Laurie Barefoot

CONTACT

S

Shrikanta Chattopadhyay

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

9

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