Wu Han Shi

Researchers are investigating the use of a new molecular imaging probe called gallium 68-labelled fibroblast activation protein inhibitor (68Ga-FAPI) for diagnosing various malignant tumors. Fibroblast activation protein (FAP) is highly present in cancer-associated fibroblasts found in the tumor environment and plays a role in tumor growth and spread. Current imaging methods like CT and MRI mainly show anatomical details, while 68Ga-FAPI PET/CT aims to provide more precise molecular-level information to improve tumor detection and staging. Previous small studies have shown promising results, so this larger study aims to confirm the diagnostic value of 68Ga-FAPI PET/CT in different cancers. Participants receive an intravenous injection of 68Ga-FAPI, with the dose adjusted by body weight (about 1.85-3.7 MBq/kg). After 20 to 60 minutes, a PET/CT scan is performed to visualize tumor locations by targeting FAP in tumor stroma. This approach combines anatomical and molecular imaging to enhance sensitivity and specificity compared to traditional imaging and the commonly used 18F-FDG PET/CT. The study focuses on assessing the diagnostic accuracy of 68Ga-FAPI PET/CT for staging malignant tumors. During the study, participants undergo the 68Ga-FAPI injection and PET/CT scan, with researchers monitoring the imaging results over three years to determine diagnostic sensitivity and specificity. The study involves consenting adults with suspected or confirmed malignant tumors. Safety monitoring includes tracking adverse reactions and verifying eligibility criteria such as pregnancy status and recent participation in other trials. The goal is to better understand how well 68Ga-FAPI PET/CT works in detecting and staging cancers across a broad patient group.

Researchers are evaluating the effectiveness and safety of 68Ga-PSMA-11 PET/CT or PET/MRI scans in detecting biochemical recurrence of prostate cancer in Chinese male patients. This prospective, open-label, single-arm, multicenter phase 3 study focuses on patients who have experienced a rise in PSA levels after radical prostatectomy or radical radiotherapy. The study aims to assess how accurately 68Ga-PSMA-11, a new tracer called Illuccix®, identifies recurrent prostate cancer compared to histopathology, PSA monitoring, and conventional imaging over a 12-month period. Participants receive a single intravenous dose of 68Ga-PSMA-11 ranging from 111 to 259 MBq administered over 3 to 5 minutes. PET/CT or PET/MRI scans are then performed between 50 and 100 minutes after the injection. These imaging procedures help detect tumor recurrence at the patient level. The study does not mention additional treatment or comparator groups. It is conducted across multiple centers in China, focusing on this specific patient population. During the study, participants undergo scheduled PET scans and clinical monitoring including PSA measurements and follow-up imaging to confirm the presence of recurrent tumors. The main outcome measured is the positive predictive value of the imaging tests for detecting prostate cancer recurrence confirmed by biopsy, clinical markers, or imaging over one year. Safety and tolerability of the tracer and imaging procedures are also observed to ensure participant well-being throughout the study.

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are evaluating the effects of adding SG301 injection to pomalidomide and dexamethasone in adults with relapsed or refractory multiple myeloma who have had at least one prior treatment including lenalidomide and a proteasome inhibitor. This phase III, randomized, placebo-controlled, double-blind study aims to compare SG301 combined with pomalidomide and dexamethasone against placebo combined with these drugs. The study includes two stages: a dose exploration phase to determine the recommended dose of SG301, followed by a randomized controlled phase to assess treatment outcomes. Participants will receive SG301 or placebo as an intravenous infusion weekly for 8 weeks, then every two weeks thereafter. All participants will take pomalidomide capsules orally at 4 mg once daily on days 1 through 21 of each 28-day cycle. Dexamethasone will be given orally or intravenously at 40 mg on days 1, 8, 15, and 22 of each 28-day cycle, with a reduced dose for participants with low body mass index. The study treatment continues through these cycles, with dosing and treatment monitored carefully. Participants will be monitored for adverse events from the first dose through about 30 days after the last dose, with follow-up lasting up to approximately 4 years. Disease progression and survival will be tracked regularly, with assessments every 4 weeks initially and then every 8 weeks after randomization. The study includes evaluations of organ function, disease status, and safety to gather comprehensive data on the treatments' impact and participant well-being throughout the trial period.

Researchers are evaluating the combination of hyperthermic intraperitoneal chemotherapy (HIPEC) with systemic chemotherapy and immune checkpoint inhibitors in patients who have gastric cancer that has spread to the peritoneum. This phase II clinical trial aims to assess how this combined treatment affects the rate of complete tumor removal (R0 resection) and also studies its impact on overall survival, progression-free survival, peritoneal cancer index (PCI), and treatment side effects. Gastric cancer with peritoneal metastasis is an advanced condition with poor prognosis, so new treatment options are important to improve outcomes. The treatment plan includes HIPEC using oxaliplatin heated in saline at 43°C for 60 minutes performed after laparoscopic surgery. Patients also receive systemic chemotherapy with oxaliplatin and S-1 in cycles every three weeks, and immune checkpoint inhibitor therapy with tislelizumab every three weeks. The study examines the safety and effectiveness of this combined approach in patients with limited peritoneal cancer spread (PCI ≤12). Participants will undergo laparoscopic exploration to confirm eligibility and receive the combined treatments as described. Researchers will monitor tumor removal success after one year and evaluate survival outcomes alongside adverse reactions. Throughout the study, patients will have regular assessments to track treatment effects and safety. The trial includes adults aged 18 to 75 years with confirmed gastric cancer peritoneal metastasis who meet specific health criteria and agree to participate.

Researchers are evaluating the safety, effectiveness, and cell metabolism of CT1195E cells, a universal CD19/CD20 CAR-T cell therapy, in adults with moderate to severe refractory Systemic Lupus Erythematosus (SLE). This early phase 1, open-label, dose escalation study involves patients aged 18 to 65 who have active SLE despite prior treatment. The study aims to find the maximum tolerated dose and explore the therapy's impact on disease activity and safety. The study consists of two main parts: a dose escalation phase and a dose expansion phase. In the dose escalation phase, participants receive one of three increasing doses of CT1195E cells through infusion, starting at 3.0 × 10^8 cells and going up to 6.0 × 10^8 cells. Researchers monitor safety and cell metabolism to decide whether to increase, decrease, or maintain doses, with a 28-day period to observe dose-limiting toxicities. The dose expansion phase involves treating additional patients at selected dose levels to further assess safety and effectiveness without additional dose-limiting toxicity observation. Participants will be closely monitored throughout the study and for up to 180 days after infusion for adverse events and treatment effects. Evaluations include laboratory tests, antibody levels, organ function measures, disease activity scores, and cell metabolism assessments. Safety monitoring includes observing toxicity severity and incidence within 28 days and adverse events over 180 days. The study may last several months per participant, depending on dosing and follow-up schedules.

Researchers are evaluating the safety, effectiveness, cell metabolism, and pharmacodynamics of ct1190b cells in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). This early phase 1 clinical trial focuses on adolescents, children, and adults who have this specific leukemia type that is positive for CD19 and/or CD20 markers. The study aims to explore different doses and understand how the treatment affects the disease and the body's cellular response. The study is divided into two phases: dose escalation and dose expansion. Participants are grouped by age: adults 18 years and older receive fixed doses of ct1190b cells at three increasing levels, while adolescents and children aged 12 to 17 receive weight-based doses at two levels with maximum total cell limits. The dose adjustments follow a specific "i3+3" design to ensure safety and effectiveness. Doses may be increased, decreased, or extended based on participant responses and cell metabolic data. The treatment involves injections of specially modified allogeneic T cells designed to reduce immune rejection. Participants undergo various assessments during the study to monitor safety and treatment effects. Researchers track the number and severity of dose-limiting toxicities within 28 days after infusion and record adverse events over 12 months. Evaluations include blood and bone marrow tests to confirm leukemia markers, organ function tests, heart function assessments, and oxygen levels. Male participants who are sexually active must use effective contraception for one year after treatment and avoid sperm donation during this time. The trial plans to enroll 18 to 36 participants, with careful safety monitoring throughout the study.

Researchers are evaluating the safety, effectiveness, metabolic behavior, and pharmacodynamics of CT1182 cells in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). This early phase 1, open-label study aims to identify the maximum tolerated dose (MTD) of CT1182 by exploring four dose levels using a dose escalation design. The study focuses on patients who have previously received standard treatments but require new therapy options due to intolerance or disease progression. Participants receive intravenous infusions of CT1182 injection, a biological therapy developed to target CD19 and CD20 markers on cancer cells using a lentiviral vector platform that creates functional CAR-T cells in the body. The study plans to enroll between 3 to 24 participants, starting with lower doses and adjusting based on safety and response. Dose limiting toxicities (DLTs) are monitored for 28 days after the first infusion to determine if dose adjustments are needed. Treatment may continue or stop based on safety evaluations and clinical benefit. During the study, participants undergo regular assessments including monitoring for adverse events, blood tests for organ function, and evaluations of immune cell expansion. Researchers track the frequency, type, and severity of side effects up to 24 months after infusion and closely observe for any dose limiting toxicities within the first 28 days. The study requires participants to meet specific health and laboratory criteria and includes pregnancy testing and contraception requirements for participants of childbearing potential. Overall participation depends on initial screening and ongoing safety monitoring throughout the trial.

Researchers are evaluating the safety and effectiveness of Adebrelimab combined with SHR-8068 and chemoradiotherapy as a perioperative treatment for patients with locally advanced rectal cancer that can be surgically removed. This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in phases II and III. It aims to assess the pathological complete response rate at 12 months after treatment. Participants receive one of the following treatments: Adebrelimab combined with SHR-8068 and chemotherapy, Adebrelimab combined with chemotherapy alone, or chemotherapy alone. These treatments are given around the time of surgery to evaluate their impact on the cancer. The study compares these treatment groups to monitor safety and effectiveness in managing locally advanced rectal cancer. During the study, participants will be carefully monitored through clinical assessments and evaluations to track treatment response and safety. Researchers will measure outcomes such as the pathological complete response rate at 12 months. Participants must meet specific health and eligibility criteria and will be followed up throughout the treatment and observation periods to ensure comprehensive data collection and safety monitoring.

Abnormal lipid metabolism often occurs after organ transplantation, especially in heart transplant recipients treated with triple immunotherapy. This condition can lead to atherosclerotic cardiovascular diseases, which are major causes of transplant organ failure and death. This research aims to understand the causes of dyslipidemia after heart transplantation and its effects on transplant rejection, focusing on the role of PCSK9 and immune cell interactions. The study will establish a long-term follow-up system for patients who have undergone heart transplantation to monitor lipid changes and clarify how dyslipidemia relates to rejection. It will expand lipid-related testing by including transcriptomic, proteomic, and metabolomic analyses to better understand transplant rejection. Additionally, single-cell sequencing technology will be used to investigate how changes in lipids influence T-cell-mediated rejection in heart transplant patients. Participants will be followed over four years, during which blood lipid levels and graft/patient survival will be measured. The study will track lipid characteristics and immune responses, using various advanced technologies to assess molecular and cellular changes. This comprehensive approach aims to provide evidence for managing lipids around the time of surgery and during long-term post-transplant care.