Hashimoto's Thyroiditis

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors TCRs to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohns disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are studying the safety and effectiveness of CAR NK cells for treating relapsed or refractory B-cell related autoimmune diseases. This early phase 1 pilot study plans to enroll 15 patients to evaluate the safety, feasibility, and potential benefits of this treatment. The study also explores how well the CAR NK cells expand, persist, and deplete B cells in these patients. Participants will receive a pre-treatment of Fludarabine and Cyclophosphamide on days -5, -4, and -3, followed by an infusion of CAR NK cells. This is a single-group, open-label trial where all participants receive the study treatment. The trial monitors patients for adverse events and dose-limiting toxicities within the first 4 weeks and up to 52 weeks after infusion. During the study, participants will be closely monitored through clinical assessments and laboratory tests at multiple time points up to one year after treatment. Researchers will measure safety outcomes including adverse events and toxicities, as well as effectiveness outcomes like disease control and remission rates. The total study duration may last up to approximately three years, including follow-up to assess long-term safety and treatment effects.

Researchers are evaluating the safety, tolerability, and initial effectiveness of CD19BCMA-targeted CAR-T cell therapy in patients with refractory autoimmune diseases. This early exploratory, open-label, single-arm clinical study focuses on adults aged 18 to 70 who have autoimmune conditions that have not responded to standard treatments. The study aims to explore whether this new in vivo CAR-T therapy approach can control disease activity without prior lymphodepletion. Participants will receive an intravenous infusion of the CD19BCMA-targeted CAR-T lentiviral vector drug. After infusion, the CAR-T cells are produced directly inside the patients body. No lymphodepleting chemotherapy will be given before treatment. Following the infusion, participants will be monitored for safety and efficacy over a 24-month period to assess disease control and treatment tolerability. During the study, participants will undergo regular safety assessments to monitor adverse events at multiple time points including Day 28, and Months 2, 3, 6, 12, 18, and 24. Researchers will track the maximum tolerated dose within 28 days after infusion. Additional evaluations will include clinical and laboratory tests to assess disease response and patient health. The total participation length can be up to two years, allowing long-term observation of treatment effects and safety.

Researchers are studying the use of unlicensed cryopreserved cord blood units CBUs for transplantation in both children and adults with blood cancers and other related disorders. This observational study involves patients with hematologic malignancies and various inherited and acquired disorders affecting the blood and immune system. The main goal is to monitor how well neutrophil recovery occurs after transplantation using these unlicensed CBUs in multiple institutions. Participants receive unlicensed cryopreserved CBUs as part of their transplant treatment. The study includes patients of any age receiving these CBUs for approved indications. The protocol focuses on the access and distribution of these unlicensed units rather than a specific treatment intervention. The study gathers data from recipients who receive these CBUs, tracking outcomes after transplantation. Participants are monitored for neutrophil recovery at 60 and 100 days after transplant, defined by a neutrophil count of at least 500mm3. Researchers also collect information on infection transmission, infusion reactions, survival rates at one year, and incidence of acute and chronic graft versus host disease. Platelet recovery is also evaluated. Safety and efficacy outcomes are followed over time to better understand the effects of unlicensed CBUs in this patient population.

Researchers are evaluating anitocabtagene autoleucel anito-cel, a BCMA-directed CAR-T cell therapy, in adults with generalized myasthenia gravis GMG classified as MGFA Grade 2 to 4a. This Phase 1 open-label, multi-center study aims to assess the safety, tolerability, and preliminary efficacy of anito-cel in patients who require immunosuppressive therapy as determined by their neurologist. The study focuses on identifying dose-limiting toxicities DLTs, the maximum tolerated dose MTD, and selecting the recommended Phase 2 dose RP2D for treatment. The study includes sequential phases screening, enrollment with leukapheresis to collect cells, pretreatment with a standard lymphodepletion chemotherapy regimen for 5 days, and a single intravenous infusion of anito-cel cells. Optional bridging therapy may be given while the CAR-T cells are prepared. Following infusion, participants will be closely monitored for safety and efficacy outcomes over time. Participants will undergo safety monitoring for at least 28 days after infusion, with safety data collected throughout the study duration of up to 24 months. Clinical effects will be evaluated using measures including the Myasthenia Gravis Activities of Daily Living MG ADL score, Quantitative Myasthenia Gravis QMG score, and Myasthenia Gravis Composite MGC scale. Additionally, blood tests will monitor autoantibody levels and pharmacokinetics of the therapy. This comprehensive follow-up ensures careful assessment of treatment impact and participant health.

This research aims to evaluate the effects of thyroid hormone supplementation in patients undergoing hemodialysis who have elevated thyrotropin TSH levels, a common complication in chronic kidney disease. Previous studies have shown that higher TSH levels are linked to poorer quality of life and increased cardiovascular risks in these patients. The trial seeks to clarify whether levothyroxine treatment can improve patient-centered outcomes and cardiovascular health, as well as its metabolic effects in this population. Participants will be randomly assigned to receive either levothyroxine or a matching placebo for 24 weeks. Initial doses depend on their TSH levels, with adjustments after 8 and 16 weeks based on follow-up TSH measurements, aiming to maintain TSH within a target range. Both groups undergo similar pill titration schedules to maintain study balance. The trial is double-blind and placebo-controlled to ensure unbiased results. During the study, participants will have assessments of quality of life, coronary artery calcification, physical performance, endothelial function, vascular markers, body fat, muscle strength, heart function, and energy expenditure at baseline and after 24 weeks. These evaluations help researchers determine the impact of levothyroxine on health-related quality of life and cardiovascular parameters. The total study participation spans approximately six months with regular monitoring.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of an mRNA drug called ABO2203, which encodes a CD19CD3 T cell engager, in patients with autoimmune diseases that have not responded well or have relapsed after standard treatments. This early phase 1 study focuses on patients with refractory autoimmune diseases who have shown inadequate response to standard care or have relapsed. The study involves administering ABO2203 injection as the investigational treatment. It includes a dose escalation phase to determine appropriate dosing and a dose expansion phase to further assess safety and preliminary efficacy. Participants will receive the study drug under medical supervision, with close monitoring throughout the treatment period. Participants will be observed from the first dose of the study treatment up to 30 days after the last dose for any treatment-emergent adverse events, including serious events and those causing interruption or early termination of treatment. The research team will carefully monitor these safety outcomes while also assessing how the drug behaves in the body. The study is expected to continue until December 2028, and participants will be involved during the treatment and follow-up periods as scheduled by the research team.

Researchers are evaluating how well multiparametric ultrasound mpUS imaging can examine and provide information about cancerous and non-cancerous tissues. This study compares mpUS, which combines different ultrasound methods to show detailed tissue structure and blood flow, with standard ultrasound and other tests. The goal is to see if mpUS can offer a more accurate assessment, especially for pancreatic cancer and thyroid nodules. Participants will receive additional mpUS imaging during their standard ultrasound procedures, which adds about 5 to 15 minutes of scan time. There are three groups patients at high risk for pancreatic cancer undergoing endoscopic ultrasound, patients with pancreatic ductal adenocarcinoma receiving endoscopic ultrasound-guided biopsies, and patients having thyroid nodule biopsies. Healthy volunteers without cancer or thyroid nodules may also join. During the study, participants will undergo mpUS imaging alongside their usual care scans. Researchers will collect the extra ultrasound data to evaluate the feasibility of mpUS imaging. The main outcome is assessing how well mpUS works during the imaging procedures. This study is non-randomized, has no masking, and will continue until November 2027. Participants may be followed up as agreed, and the total added scan time is brief.

Researchers are evaluating the use of online outpatient follow-up compared to traditional offline follow-up for patients who have undergone surgery for papillary thyroid cancer. This randomized controlled trial aims to assess the adherence to outpatient procedures over a 12-month period. The study includes adults between 18 and 90 years old who have had thyroid surgery and are able to communicate in Chinese and use the internet for visits. Participants are randomly assigned to one of two groups one group uses the Huayitong app for their post-operative follow-up, while the other group attends standard in-person outpatient clinics. The study will monitor participants through three follow-up visits at 1, 3, and 6 months after surgery. Participants assigned to online visits may switch to offline visits or withdraw from the trial if technical issues arise or additional medical care is needed. During the study, investigators collect demographic and medical information, details of symptoms and treatment, patient satisfaction, and other relevant data through questionnaires and electronic medical records. Safety is monitored through a review of medical records and participant surveys 30 days after the final follow-up. The main outcome measured is adherence to outpatient procedures, with secondary outcomes including general quality of life.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of GenSci136 in healthy adult volunteers. This randomized, double-blind, placebo-controlled Phase 1 trial aims to study a single subcutaneous injection of GenSci136. The study focuses on how the drug behaves in the body and its effects, while monitoring for any adverse reactions over time. Participants will receive single ascending doses of GenSci136 or a placebo administered under the skin. The study is designed with dose escalation to evaluate different amounts of the drug. Both the experimental drug and placebo are given through subcutaneous injections in a controlled setting. During the study, participants will be closely observed from Day 1 through Day 113. Researchers will monitor for treatment-emergent adverse events and serious adverse events to assess safety. Blood samples will be collected to measure drug concentration, its maximum level, time to reach maximum level, elimination half-life, and other pharmacokinetic parameters. In addition, changes in specific biomarkers related to immune response will be measured. The trial involves regular visits and assessments over approximately 16 weeks to ensure thorough monitoring and data collection.