Biospecimen Collection for Autoimmune Diseases
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to uncover new treatment targets for autoimmune diseases by studying T cells (a type of immune cell) in inflamed tissues. Researchers seek to identify specific targets these T cells latch onto, which can aid in developing treatments to ease the immune system's attack on the body. Participants with conditions like Crohn’s disease, celiac disease, multiple sclerosis, or scleroderma, who are undergoing standard medical procedures, might be suitable candidates. The trial involves collecting companion blood samples during these procedures to learn more about the disease process. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to groundbreaking advancements in autoimmune disease therapies.
Will I have to stop taking my current medications?
You can continue taking your current medications if they are not known to be directly harmful to T cells. However, if you are on medications that are toxic to T cells, you may need to stop them for at least 4 weeks before participating in the trial.
What prior data suggests that this biospecimen collection method is safe for patients with autoimmune diseases?
Research has shown that taking extra blood samples during trials is generally safe for participants. These samples are typically collected during regular medical procedures like biopsies or endoscopies. Previous studies using similar methods have not identified any major safety issues.
For autoimmune diseases, these blood samples help scientists understand how certain immune cells, called T cells, function. This knowledge can lead to new treatments. The procedures are standard, and blood draws are common in medical care, so most people tolerate them well.
In summary, based on research and usual medical practices, taking extra blood samples in this study is considered safe.12345Why are researchers excited about this trial?
Researchers are excited about the "Biospecimen Collection for Autoimmune Diseases" trial because it aims to gather comprehensive data from various autoimmune conditions like systemic sclerosis, inflammatory bowel diseases, and multiple sclerosis, among others. Unlike standard treatments that focus primarily on managing symptoms, this study seeks to collect and analyze biological samples from patients to better understand the underlying mechanisms of these diseases. This approach could lead to more precise and personalized treatments in the future. By examining companion blood samples and excess materials from routine clinical procedures, researchers hope to uncover new insights that could revolutionize how autoimmune diseases are diagnosed and treated.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Biospecimen Collection
Collection of tissue samples from patients with active autoimmune disease for analysis of T cell targets
Analysis and Target Identification
Analysis of collected samples to identify T cell targets using TScan's technology
Follow-up
Participants are monitored for safety and effectiveness after biospecimen collection
What Are the Treatments Tested in This Trial?
Interventions
- Companion blood samples
How Is the Trial Designed?
9
Treatment groups
Experimental Treatment
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
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
These samples will have been collected from patients with autoimmune diseases, at any one time point after diagnosis and with a companion blood sample.
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.
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
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
Serial sampling of excess materials, with companion blood samples, can be obtained at intervals consistent with excess materials collected for clinical care.
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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
TScan Therapeutics, Inc.
Lead Sponsor
Citations
Companion blood samples with procedure i Multipel skleros ...
The most clinically meaningful way to discover new targets of T cells in autoimmune diseases is to study the tissues of patients with active ...
2.
astrazeneca.com
astrazeneca.com/content/astraz/what-science-can-do/topics/next-generation-therapeutics/immunology-cell-therapy.htmlAiming to reset the immune system to transform immunology
Discover how AstraZeneca are pioneering cell therapies that have the potential to provide remission in immune-mediated diseases.
Overview of Select Autoimmune Diseases - NCBI - NIH
Sjögren's disease, SLE, APS, rheumatoid arthritis, psoriasis, IBD, celiac disease, PBC, multiple sclerosis, type 1 diabetes, and autoimmune thyroid diseases
4.
ajmc.com
ajmc.com/view/fda-approves-gene-therapy-onasemnogene-abeparvovec-for-broader-sma-populationFDA Approves Gene Therapy Onasemnogene ...
Onasemnogene abeparvovec-brve is now the first gene replacement therapy approved for spinal muscular atrophy in patients 2 years and older.
Prospective Cohort of Patients With Systemic Sclerosis
The goal of the study is to collect important information about patients' health over time and gather biological samples, such as blood, stool, and skin swabs.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.