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

Conditions

• Ankylosing Spondylitis
• Autoimmune Diseases
• Birdshot Chorioretinitis
• Celiac Disease
• Crohn&Amp;#39;s Disease
• Multiple Sclerosis
• Non-radiographic Axial Spondyloarthritis (Nr-axSpA)
• Scleroderma
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Companion blood samples with procedure — 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.

Study Details

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.

Key Dates

Start date

Jan 3, 2023

Status verified

Nov 2025

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: Inflammatory Bowel Diseases- Crohn's Disease and Ulcerative Colitis
  Group A: IBD-Treatment Naïve Crohn's: Patients that are scheduled to have an endoscopic procedure to confirm a suspected diagnosis of Crohn's disease and are not currently on any Crohn's directed treatment. Group B: IBD-On-Treatment Crohn's: Patients with an established diagnosis of Crohn's disease and are only on treatments that are allowed under this protocol (see Inclusion and Exclusion criteria) and consent to have extra biopsies obtained from inflamed and normal colon for research purposes during a planned endoscopy for their standard clinical care. Group C: IBD-Ulcerative Colitis: Patients with established or suspected diagnosis of ulcerative colitis who may be on treatments that are allowed under this protocol (see Inclusion and Exclusion criteria). Interventions: Companion blood samples with colonoscopy and biopsies for participants with Crohn's Disease or Ulcerative Colitis
• Arm: Celiac Disease: Small intestine endoscopic biopsies obtained during endoscopy
  Group A Celiac Disease: Excess small intestine biopsies obtained during endoscopy from patients with celiac disease or from patients who are suspected to have celiac disease. A companion blood sample will be drawn on or around the same day. Group B Celiac Disease: Patients who are suspected to have celiac disease or are known to have celiac disease and who undergo a research endoscopy of the small intestine to obtain biopsy samples from the small intestine. A companion blood sample will be drawn on or around the same day. Interventions: Companion blood samples with upper endoscopy and biopsies.
• Arm: Ankylosing spondylitis or non-radiographic axial spondyloarthritis (nr-axSpA) (HLA-B27 positive)
  Group A ankylosing spondylitis- arthrocentesis: HLA-B27 positive patients with known or suspected ankylosing spondylitis or nr-axSpA with inflammatory joint involvement who consent to arthrocentesis done for research purposes. A blood sample drawn on or around the same day of the procedure is also required. A minimum of 2 mL and up to 10 mL of joint aspiration fluid is required. Group B ankylosing spondylitis- surgery: HLA-B27 positive patients with known or suspected ankylosing spondylitis or nr-axSpA planned for surgery for their standard clinical care who consent to have excess materials from their resected joint tissues used for research purposes. Bone, joint or biologic materials from the surgical resection is acceptable. A blood sample drawn on or around the same day of the procedure is also required. Interventions: Companion blood samples with arthrocentesis
• Arm: Multiple Sclerosis. Excess CSF collected during lumbar puncture
  A. Multiple Sclerosis Group A: Extra CSF from standard clinical procedure in patients diagnosed with multiple sclerosis and have a planned lumbar puncture for standard clinical care where extra CSF may be obtained for standard of care. A blood sample drawn on or around the same day is required. CSF in excess of clinical laboratory requirements will be used for study purposes. 2 mL to 10 mL of CSF is required. Up to 20 patients will be recruited into research procedure group. B. Multiple Sclerosis Group B: Research CSF collection - Patients will have CSF collected during a lumbar puncture that is not required for standard clinical care and will also have a companion blood sample collected. The patient will consent to a research lumbar puncture and will be enrolled into the research CSF collection cohort. 2 mL to 10 mL of CSF is required. Up to 10 patients will be recruited into this group. Interventions: Companion blood samples with lumbar puncture
• Arm: Scleroderma. Skin tissue biopsy
  A. Scleroderma Group A: Excess Tissue - Excess skin tissue obtained during a planned skin tissue biopsy and with a companion blood sample. A minimum sample of a a single 3 mm punch biopsy is required and up to 3 punch biopsies will be allowed. Up to 10 patients will be recruited into this group. B. Scleroderma Group B: Research Skin Biopsy - Patients that agree to a research skin tissue biopsy, not otherwise clinically indicated and obtained at any one point in time, and with a companion blood sample. For skin biopsies, a minimum sample of a single 3 mm punch biopsy is required and up to 3 punch biopsies will be allowed. Up to 10 patients will be recruited into this group. Interventions: Companion blood samples with skin biopsy
• Arm: Systemic Sclerosis with pulmonary involvement
  Patients would consent to have excess materials from their bronchoscopy, bronchoalveolar lavage fluid or thoracoscopy done for standard of care purposes. Patients should not undergo these procedures unless required for standard clinical care. There is no minimum tissue requirement for this cohort. Up to 10 patients will be recruited into this group. Interventions: Companion blood samples with biopsy
• Arm: Other Autoimmune Disease such as psoriasis, vitiligo, type 1 diabetes and others
  A. Other Autoimmune Group A: Excess Biologic Material - Excess material sourced from a part of the body exhibiting clinical symptoms of autoimmune disease +/- nearby normal biologic materials, and with a companion blood sample. While there is no minimum tissue requirement for this cohort, tissue requirements from other autoimmune diseases described above may be used to guide tissue collection sample amounts. B. Other Autoimmune Group B: Research Biologic Material - Research skin tissue biopsy, other tissue biopsy or biologic materials collected from an affected part of the body +/- normal healthy biologic materials, and with a companion blood sample. In the instance of a skin biopsy, a minimum of a single 3 mm punch biopsies, and up to three, 3 mm punch biopsies, will be obtained.
• Arm: Evolving autoimmune disease
  Serial sampling of excess materials, with companion blood samples, can be obtained at intervals consistent with excess materials collected for clinical care.
• Arm: Previously cryopreserved, dissociated tissue obtained from a biobank or tissue repository
  These samples will have been collected from patients with autoimmune diseases, at any one time point after diagnosis and with a companion blood sample.

Primary Outcome Measure

Identify peptide targets together with their associated TCRs in patients with autoimmune diseases under study. [ Time Frame: 3 Years ]

Central Contacts

• Laurie Barefoot
  857-399-9930
  [email protected]
• Shrikanta Chattopadhyay
  [email protected]

Locations (12)

Find similar trials in Orange, CA

Related Studies

• Serum Auto-Antibodies in Neurological Diseases
  Enrolling By Invitation · University of California, Davis · Sacramento, California
• NARCOMS Registry: A Multiple Sclerosis Registry
  Recruiting · University of Texas Southwestern Medical Center · Dallas, Texas
• A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
  Recruiting · Center for International Blood and Marrow Transplant Research · Birmingham, Alabama
• Genes and Environment in Multiple Sclerosis
  Recruiting · Columbia University · Bethesda, Maryland