RecruitingNCT06587828

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


Sponsor

TScan Therapeutics, Inc.

Enrollment

300 participants

Start Date

Jan 3, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is trying to understand what part of the immune system is attacking the body in people with autoimmune diseases. Researchers will collect small tissue or blood samples to study specific immune cells (called T cells) and what they are targeting. **You may be eligible if...** - You are 18 or older - You have been diagnosed with (or are suspected to have) an autoimmune condition such as Crohn's disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, or another autoimmune disease - You are currently on a disease-modifying treatment that does not directly destroy T cells (such as Humira, Remicade, Tysabri, Ocrevus, or similar) - You are a good candidate for a tissue biopsy or sample collection procedure **You may NOT be eligible if...** - You are currently taking T cell-toxic medications like methotrexate, azathioprine, steroids (prednisone), JAK inhibitors (e.g., Xeljanz, Rinvoq), or certain other immunosuppressants that cannot be held for at least 4 weeks - You are pregnant or nursing - You have dementia or a condition that prevents you from giving informed consent - You have a serious allergy to local anesthetics (e.g., lidocaine) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECompanion blood samples with procedure

Participants in all cohorts will have a companion blood sample obtained on or around the time of the procedure intended to obtain tissue or fluid.


Locations(12)

Knowledge Research Center

Orange, California, United States

Cura Clinical Research

Sherman Oaks, California, United States

Arnold Arthritis & Rheumatology

Skokie, Illinois, United States

University of Kentucky Research Foundation

Lexington, Kentucky, United States

Massachusetts Eye Research and Surgery Institution (MERSI)

Waltham, Massachusetts, United States

Susquehanna Research Group

Harrisburg, Pennsylvania, United States

Nexus Research

Cranston, Rhode Island, United States

Nexus Research

Cranston, Rhode Island, United States

RI Rheumatology

Cranston, Rhode Island, United States

Palmetto Gastroenterology Clinical Research, LLC

Summerville, South Carolina, United States

Novel Research

Bellaire, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06587828


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