Immune Response

Researchers are studying the long-term effects of reducing household air pollution (HAP) from biomass fuel use on heart, lung, and immune health among women and children in semi-rural Bangladesh. The study evaluates whether a mobile phone-based behavioral change communication (mHealth BCC) intervention can increase the adoption and exclusive use of cleaner cooking fuel, Liquid Petroleum Gas (LPG). This research also investigates how lowering pollution exposure might influence immune responses to vaccines and subclinical cardiovascular and pulmonary changes. The study is a large household-level randomized controlled trial comparing two groups: one receiving the mHealth BCC intervention encouraging exclusive LPG use and a control group receiving no such intervention. Researchers will monitor personal and area levels of air pollutants like PM2.5 and black carbon before and after intervention, alongside detailed assessments including spirometry, chest X-rays, high-resolution CT scans, blood pressure, EKG, metabolic markers such as HbA1c and lipid profiles, and immune cell function. The intervention messages are delivered via mobile phone with frequency tailored to participant responses. Participants will be followed over two years with repeated measurements to assess pollutant exposure and health effects. Evaluations include lung function tests, imaging, cardiovascular markers, metabolic blood tests, and immune function assays. The study aims to provide insights into the health benefits of sustained LPG use and improved air quality. Total participation spans pre-intervention assessments through two years of follow-up, with ongoing monitoring of pollution exposure and health outcomes.

Researchers are evaluating the use of 68Ga-grazytracer PET imaging to help diagnose pseudoprogression in lung cancer patients after immunotherapy. Pseudoprogression is difficult to distinguish with current clinical methods, which often require follow-up observations that may not meet clinical needs. This study aims to assess the effectiveness and feasibility of this novel imaging agent, which targets granzyme B to show the activity of cytotoxic T cells in tumor areas. This observational study uses 68Ga-grazytracer PET/CT scans to visualize and semi-quantitatively measure granzyme B concentration in lung cancer lesions that have enlarged or developed new lesions after immune checkpoint inhibitor treatment. The study follows patients for 4-8 weeks, up to a maximum of 12 weeks, to evaluate the diagnostic performance of this imaging method in detecting pseudoprogression. Participants will undergo PET/CT imaging and be monitored over the follow-up period to assess changes and outcomes. Researchers will collect data on diagnostic accuracy and safety during this time. The study includes adult lung cancer patients aged 18 to 75 years who meet specific clinical criteria and have a life expectancy of at least six months. Total participation duration varies with the follow-up period, and patient compliance with study requirements is monitored throughout.

Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis (RA). This study focuses on understanding two main factors influencing pain relief: brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinib's impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.

Researchers are studying the stimulator of interferon gene (STING) protein, which plays an important role in the immune system's ability to detect tumors. This trial focuses on evaluating a new imaging agent called [68Ga]Ga-Sa-DABI-4, designed to noninvasively detect STING expression in the tumor environment using positron emission tomography (PET). The study aims to assess the safety, distribution in the body, and potential usefulness of this imaging agent for cancer patients. Participants will receive one intravenous injection of the investigational drug [68Ga]Ga-Sa-DABI-4 during the study. This single administration is followed by PET imaging to monitor how the agent interacts with the tumor. The study is conducted in an early phase 1 design, focusing on initial safety and diagnostic capabilities. During the trial, participants will undergo PET scans to evaluate the diagnostic effectiveness of the imaging agent within 15 days after injection. Researchers will monitor safety and how the drug distributes throughout the body. The study includes patients suspected of having or newly diagnosed with malignant diseases. Participation involves a single dosing and imaging session, with safety and diagnostic data collected during this period.

Researchers are evaluating a personalized self-DC vaccine that targets neo-antigens (Neo-DC vaccine) for treating advanced solid tumors, including head and neck cancer and certain types of non-small cell lung cancer without driver gene mutations. This study aims to explore the dose-limiting toxicity and identify the recommended dose for future Neo-DC vaccine research. About 9 patients will be enrolled, following a 3 plus 3 dose escalation design with two dose levels. Participants will receive infusions of the Neo-DC vaccine at either a lower dose (1 x 10^7 cells per infusion) or a higher dose (5 x 10^7 cells per infusion) given every 7 days. Four infusions make up one treatment cycle. If clinical benefit or certain immune responses are observed, treatment cycles may continue until four administrations are completed, disease progression occurs, new anti-tumor treatments begin, or treatment is stopped for other reasons. Dose-limiting toxicity is monitored within 28 days after the first infusion. During the study, participants will be monitored for adverse events within 28 days of the first vaccine infusion. Researchers will also assess the objective response rate over up to 2 years and observe dose-limiting toxicities in the same 28-day window. Participants must complete all study procedures, including blood collections and tumor assessments based on RECIST 1.1 standards. The total participation duration varies depending on treatment continuation and disease status.

Researchers are studying a new treatment approach for patients with surgically removable head and neck squamous cell carcinoma (HNSCC), a common and serious type of cancer in the head and neck region. The study evaluates the safety and tolerability of combining immune-targeted therapy with a lysogenic herpes simplex virus (HSV) as a neoadjuvant treatment to reduce tumor size before surgery. This innovative combination aims to improve surgery outcomes and lower the chances of cancer returning or spreading. Participants receive a combination of treatments including Tislelizumab given on days 1 and 22, and continuous daily Afatinib from days 1 to 42. They also receive injections of the lysogenic HSV virus directly into lymph nodes, with dosing based on lymph node size, given twice two weeks apart. After these treatments, patients undergo standard surgical removal of the tumor. The HSV virus injection includes an initial dose-escalation phase followed by a dose-expansion phase to find the most effective dose. During the study, patients are closely monitored for side effects and treatment tolerance, including checking for dose-limiting toxicities during surgery. Researchers will assess how well the tumor responds to treatment by examining major and complete pathological responses and overall tumor shrinkage up to eight weeks after treatment. They will also monitor adverse events for up to 12 weeks and follow disease-free survival for one year. The study duration and procedures are planned to provide detailed information on the safety and effects of this combined therapy.

Researchers are investigating treatments for locally advanced rectal cancer in this national, multicenter, randomized, placebo-controlled Phase III clinical trial. The study aims to evaluate whether combining immunotherapy with total neoadjuvant therapy (TNT) offers better benefits than long-course radiotherapy followed by TNT alone. It also compares the effectiveness and side effects of different radiotherapy types when combined with immunotherapy under TNT. Participants are assigned to one of three groups: one receives short-course radiotherapy (SCRT) followed by immunotherapy and chemotherapy; another receives long-course radiotherapy (LCRT) with concurrent chemotherapy plus immunotherapy and chemotherapy; and the third group receives LCRT with concurrent chemotherapy followed by TNT chemotherapy and a placebo instead of immunotherapy. Immunotherapy or placebo is given via intravenous infusion every three weeks for six cycles. After neoadjuvant therapy, patients may undergo surgery or opt for a watch-and-wait approach if they achieve complete remission. During the study, participants undergo dynamic monitoring including MRI and blood tests to track tumor response and minimal residual disease, especially for tumors close to the anal verge. Researchers assess outcomes such as event-free survival over three years, complete response rates, overall survival, and treatment side effects using standardized criteria. The trial includes follow-up visits and safety evaluations over several years to monitor long-term effects and treatment results.

Researchers are investigating treatments for head and neck squamous cell carcinoma (HNSCC), a common and serious cancer affecting patients' appearance and functions. The study compares the effects of adding low-dose radiotherapy to a combination of targeted therapy and immunotherapy before surgery, aiming to improve surgery outcomes and organ preservation. This Phase 2 trial follows promising earlier research showing potential benefits of combining these therapies. Participants are randomly assigned to one of two groups: one group receives low-dose radiotherapy along with targeted therapy (afatinib) and immunotherapy (tislelizumab), while the other group receives only targeted therapy and immunotherapy. Treatments include tislelizumab given intravenously on days 1 and 22, afatinib taken continuously for 42 days, and low-dose radiotherapy at 4 Gy in two fractions for the experimental group. Surgery is performed after the neoadjuvant therapies. During the study, participants undergo evaluations including intraoperative assessments of major pathologic response, pathologic complete response, and objective response rate over approximately two months of neoadjuvant therapy. The research team monitors safety, treatment effects, and surgical outcomes. Participation lasts from treatment initiation through surgery and follow-up assessments, aiming to provide new options for managing operable HNSCC.

Researchers are evaluating a combination of immune-targeted therapy and lysogenic herpes simplex virus (HSV) virotherapy as a neoadjuvant treatment for patients with surgically resectable head and neck squamous cell carcinoma (HNSCC). This study aims to improve surgical success and reduce the risk of recurrence and metastasis by using these therapies before surgery. The trial is a prospective, single-arm study focused on the safety and tolerability of this innovative approach for patients with locally advanced HNSCC without distant metastasis. Participants will receive tislelizumab on days 1 and 22, afatinib daily from days 1 to 42, and injections of lysogenic HSV virus into lymph nodes in two doses spaced two weeks apart. The virus dose will be adjusted based on lymph node size, with a dose-escalation phase followed by a dose-expansion phase using the most effective dose. After these treatments, patients will undergo standard surgery to remove the tumor. During the study, researchers will monitor participants for dose-limiting toxicities during surgery and evaluate responses such as major pathologic response and complete pathologic response. Additional assessments include adverse events up to 12 weeks, objective response rate up to 8 weeks, and one-year disease-free survival. Participants will attend scheduled visits for treatment administration, surgery, and follow-up to assess safety and treatment effects throughout the trial period.

Researchers are investigating a combination of zoledronic acid and interleukin 2 that boosts a specific immune cell subset called Vb32Vb42 T cells, alongside standard anti-tuberculosis chemotherapy, to treat multidrug-resistant tuberculosis (MDR-TB). MDR-TB is a serious form of drug-resistant TB with limited cure rates despite current treatments. This study explores immunotherapy as a new approach to help patients who respond poorly to existing drug regimens. Participants receive treatment following WHO guidelines for drug-resistant TB. One group gets standard MDR-TB treatment plus intravenous zoledronic acid three times and subcutaneous recombinant human interleukin 2 ten times over six months. The other group receives only the standard MDR-TB treatment regimen. The immunotherapy aims to expand and activate Vb32Vb42 T cells to better fight the infection. During the study, researchers monitor participants for changes in sputum smear and culture results, with an average follow-up of 24 months. They also assess lung changes through radiographic imaging over this period. The study collects data on immune response and treatment effectiveness while following participants closely to evaluate safety and disease progression from start to completion.