Is NCT06587828 recruiting in Lexington, KY?

Yes, NCT06587828 is currently recruiting participants at its Lexington, KY location. This autoimmune diseases clinical trial is actively enrolling qualified participants.

How do I join the autoimmune diseases clinical trial in Lexington?

To join this clinical trial in Lexington, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Lexington clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Autoimmune Diseases Clinical Trial in Lexington, KY

About This Autoimmune Diseases Study in Lexington

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.

Sponsor: TScan Therapeutics, Inc.

Who Can Participate

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lexington?

Yes, this clinical trial (NCT06587828) has an active research site in Lexington, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autoimmune Diseases Treatment Options in Lexington, KY

If you're searching for autoimmune diseases treatment options in Lexington, KY, this clinical trial (NCT06587828) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lexington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced autoimmune diseases specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autoimmune diseases clinical trials near you to find additional studies recruiting in your area.

Autoimmune Diseases Clinical Trial in Lexington, KY

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