Immune Modulator

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 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 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 evaluating the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis (ABPA), a condition that often affects people with severe bronchial asthma. The study follows guidelines from ISHAM for ABPA diagnosis and treatment, aiming to understand how biologics can impact this condition. This is a prospective, multicenter observational cohort study sponsored by Qianfoshan Hospital. Participants receive standard medical treatment consisting of oral prednisone with a tapering dose over several weeks, with or without oral voriconazole. Some patients also receive biological agents combined with this standard therapy for at least four months, following GINA2025 guidelines. The biologics are given alongside existing asthma treatments, such as inhaled corticosteroids and long-acting beta-agonists. The study compares groups receiving biologics plus standard treatment versus standard treatment alone. During the study, researchers monitor participants for one to two years, assessing the number of exacerbations, hospitalizations, time to first exacerbation, remission rates, glucocorticoid use, asthma control, and various immune markers such as serum IgE and eosinophil counts. Safety and overall mortality are also tracked. This extensive follow-up includes measuring treatment responses at eight weeks and ongoing assessments to evaluate long-term effects and disease control.

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.

Researchers are investigating personalized precision medicine for adults aged 18 to 75 with psoriasis or psoriatic arthritis. This multi-center randomized clinical trial compares a prescreen strategy-based biologics selection using immune cell biomarkers versus standard guideline-based biologics treatment. The study also explores cardiovascular biomarkers to understand disease impact and treatment effects. Participants are randomly assigned to one of two groups: a strategic group where biologics are selected based on individual immune cell screening and biomarker scores, and a standard group receiving biologics per current guidelines without prescreening. Biologics studied include adalimumab, etanercept, certolizumab pegol, golimumab, ustekinumab, secukinumab, ixekizumab, bimekizumab, and brodalumab. Blood samples are cultured to analyze cytokine responses, with follow-up visits scheduled at multiple intervals up to 72 weeks, extending up to 3 years if needed. Participants undergo clinical assessments including Psoriasis Area and Severity Index (PASI), joint counts, Disease Activity in Psoriatic Arthritis (DAPSA) score, Dermatology Life Quality Index (DLQI), and body surface area affected. Cardiovascular health is monitored by measuring internal carotid artery thickness at 6 months, 1 year, and 2 years. Researchers also collect data on pruritus and cytokine levels to evaluate treatment effects. Safety and efficacy outcomes are assessed regularly throughout the study period, with extended follow-up for up to 5 years.

Researchers are evaluating budoprutug, a humanized monoclonal antibody targeting CD19, in adults with immune thrombocytopenia (ITP), a condition characterized by low platelet counts. This Phase 1b/2a open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical effects of budoprutug in patients with platelet counts below 30,000/µL despite prior treatment attempts. The study is sponsored by Climb Bio, Inc. Participants will receive budoprutug as two intravenous infusions administered 14 days apart. The study includes sequential cohorts with escalating doses, followed by a dose expansion group. Each participant receives a single IV dose on Day 1 and another on Day 15. The trial monitors the effects of budoprutug on platelet counts and CD20+ B-cell levels, among other factors. Throughout the study, participants will be closely monitored up to 48 weeks for treatment-related side effects, blood levels of the drug, immune cell changes, platelet responses, and the development of anti-drug antibodies. Safety labs including coagulation tests and bilirubin levels will be assessed. The study does not include placebo groups and participation involves scheduled visits for infusions and follow-up evaluations to track both safety and preliminary clinical outcomes over nearly a year.