Wu Han Shi

Researchers are investigating the diagnostic potential of a new molecular imaging probe called gallium 68-labelled fibroblast-activation protein inhibitor 68Ga-FAPI in detecting various malignant tumors. Fibroblast-activation protein FAP is commonly found in cancer-associated fibroblasts within tumor tissue and plays a role in tumor growth and spread. This study aims to confirm the advantages of 68Ga-FAPI over traditional imaging methods like 18F-fluorodeoxyglucose 18F-FDG PETCT, which can sometimes give false positive or negative results in certain cancers. Participants who have undergone whole-body 18F-FDG PETCT scans for suspected or confirmed malignancies, particularly tumors with low FDG uptake such as glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases, will receive a whole-body 68Ga-FAPI PETCT scan within one to four weeks. The 68Ga-FAPI is injected intravenously with a dose based on body weight, and imaging is performed 20 to 60 minutes after injection. This interventional study evaluates how well 68Ga-FAPI PETCT can diagnose and stage malignant tumors. During the study, participants will undergo the 68Ga-FAPI PETCT scan and be monitored for diagnostic sensitivity and specificity over three years. Researchers will also assess the prognostic value of FAPI PET parameters up to one year post-treatment, evaluate therapeutic response within one week after completion of therapy, and explore correlations between PET imaging and histopathological biomarkers within four weeks of the scan. The study includes informed consent and follow-up assessments to understand the imaging methods overall effectiveness in managing cancer.

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers are studying relapsed or refractory multiple myeloma in adults who have already received treatment with lenalidomide and a proteasome inhibitor but whose disease has progressed. The study aims to evaluate the effects of adding SG301 injection to the standard treatment of pomalidomide and dexamethasone. This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial. The study has two stages. Stage 1 is to find the right dose of SG301 combined with pomalidomide and dexamethasone. Stage 2 randomly assigns participants to receive either SG301 injection plus pomalidomide and dexamethasone or a placebo plus the same drugs. SG301 and its placebo are given by intravenous infusion weekly for 8 weeks, then every 2 weeks. Pomalidomide capsules are taken orally once daily on days 1 to 21 of each 28-day cycle. Dexamethasone is taken orally or by infusion on days 1, 8, 15, and 22, with dose adjusted for low body weight. Participants continue treatment until their disease progresses, unacceptable side effects occur, or other stopping criteria are met. Researchers will monitor side effects, drug levels in the body, immune response, and treatment effects including progression-free survival and overall survival for up to about 4 years. The study includes regular assessments every 4 weeks initially, then every 8 weeks, with safety followed for about 30 days after treatment ends.

Researchers are evaluating a treatment approach for patients with gastric cancer that has spread to the peritoneum, an advanced disease stage with poor prognosis. This phase II clinical trial aims to study the effect of combining hyperthermic intraperitoneal chemotherapy HIPEC with systemic chemotherapy and immune checkpoint inhibitors on the rate of complete tumor removal R0 resection. The study also examines overall survival, progression-free survival, tumor burden, and treatment side effects in these patients. The treatment involves HIPEC using oxaliplatin heated to 43C for 60 minutes following laparoscopic surgery, combined with systemic chemotherapy SOX regimen including oxaliplatin and S-1 and immune checkpoint inhibitor therapy with tislelizumab given every three weeks. Participants will receive this combined regimen to assess its safety and potential to improve outcomes for peritoneal metastasis from gastric cancer. Participants will undergo laparoscopic exploration to confirm eligibility, followed by treatment and regular follow-up for up to three years. Researchers will monitor tumor removal success, survival rates at 1, 2, and 3 years, progression-free survival, and adverse reactions. The study includes detailed assessments of organ function, performance status, and adverse events throughout the treatment and observation period to evaluate safety and effectiveness.

Researchers are evaluating the safety, efficacy, and cellular metabolism of CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma B-NHL. This clinical study is a single-arm, open-label, dose exploratory trial designed to enroll between 6 and 24 participants. It aims to assess how these CAR-T cells behave and affect the disease in this patient population under medical supervision. Participants will receive infusions of CT1190B and CT1190B-P cells as the experimental treatment. The study does not include a comparison group and focuses on evaluating the dose range and maximum tolerated dose within 28 days after infusion. The treatment involves a single-arm administration of chimeric antigen receptor T cells, and participants will be followed for up to 12 months to monitor responses and safety outcomes. Throughout the study, participants will undergo various assessments including monitoring of the dose effects, overall and complete response rates at multiple time points 4, 8, 12 weeks and 6, 9, 12 months, duration of remission, progression-free survival, and overall survival up to 12 months after treatment. Participants must adhere to a long-term follow-up plan extending up to 15 years as required by regulatory guidelines. Safety evaluations and cellular pharmacokinetics will also be monitored during the study period.

Researchers are evaluating the safety, effectiveness, and cell metabolism of ct1195e cells in adults with moderate to severe refractory Systemic Lupus Erythematosus SLE. This early phase 1 study explores dose levels and cellular responses to better understand this therapys potential. The trial aims to find the maximum tolerated dose and assess side effects and disease activity over time. Participants receive infusions of CT1195E CAR-T cells in a two-stage process an initial dose escalation phase with three planned dose levels 3.0 x 108, 4.5 x 108, and 6.0 x 108 cells followed by a dose expansion phase selecting one or more dose groups for further evaluation. Dose decisions are based on safety, tolerance, and cell metabolism, with a 28-day dose-limiting toxicity observation period after infusion. During the study, participants are monitored through assessments of toxicity, adverse events, and SLE disease activity using various clinical scores and biomarker changes. Follow-up includes evaluations at multiple time points up to one year to measure cell gene presence and immune function. Safety data and disease responses guide ongoing treatment decisions and participant management throughout the trial.

Researchers are investigating the safety, effectiveness, and cellular metabolic behavior of ct1190b cells in patients with relapsed or refractory B-cell acute lymphoblastic leukemia B-ALL. This open-label, early phase 1 trial focuses on patients with CD19 andor CD20 positive B-ALL who have not responded to standard treatments or have relapsed. The study aims to better understand how the ct1190b cells work in the body and their potential impacts on this serious form of leukemia. Participants receive ct1190b CAR-T cell injections, which are genetically modified T cells targeting CD19 and CD20 proteins on leukemia cells. The study includes a dose escalation phase with different dosing levels for adults 18 years and adolescentschildren 12-17 years. Adults receive doses from 3.0 to 6.0 x 108 CAR-T cells, while younger participants receive doses based on body weight with limits on total cells infused. Dose adjustments may be made based on safety, effectiveness, and cellular metabolism data throughout the trial. During the study, participants are closely monitored with tests and evaluations over 12 months after cell infusion. Researchers assess adverse events, response rates, remission duration, survival, and gene levels of ct1190b cells at multiple time points. Safety is evaluated mainly within 28 days and throughout the year. Participants undergo regular clinical and laboratory assessments to track treatment effects and side effects. The total study duration includes follow-up to understand long-term outcomes and cellular behavior after treatment.

Researchers are evaluating CT1182, an in vivo CAR-T cell therapy, in patients with relapsed or refractory B-cell Non Hodgkin Lymphoma rr B-NHL. This early phase 1, open-label study aims to explore the safety, effectiveness, metabolic behavior, and pharmacodynamics of CT1182 cells. The study intends to identify the maximum tolerated dose MTD by testing four dose levels, with a target toxicity probability of 30%, to understand how the treatment affects patients with various subtypes of B-NHL. Participants will receive intravenous infusions of CT1182 at escalating dose levels ranging from 1.2 108 to 1.2 109 TU. The dose escalation follows a Bayesian Optimal Interval design, with safety monitored over a 28-day dose-limiting toxicity DLT observation period after the first infusion. If no DLT is observed, doses may be adjusted if ineffective expansion of CAR-T cells is detected, early withdrawal or continued safety observation is possible. The study plans to enroll between 3 and 24 participants, with dosing and cohort size adjusted according to ongoing results. During the study, participants will be closely monitored for adverse events, DLTs, and response rates for up to 24 months after infusion. Evaluations include clinical assessments, laboratory tests, and measurement of CAR gene copy numbers at multiple timepoints. Outcome measures include safety profiles, objective and complete response rates, duration and time to remission, progression-free survival, overall survival, and metabolic kinetics of the lentiviral vectors used in treatment. The study follows participants through long-term safety and efficacy assessments to better understand CT1182s impact.

Researchers are evaluating the safety and tolerability of PET imaging using a single intravenous infusion of 68GaGa-ELI421 injection in men with prostate cancer. This study also aims to assess the distribution, radiation exposure, and diagnostic effectiveness of 68GaGa-ELI421 PET imaging. It is a Phase 1 and Phase 2 interventional trial conducted by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants will receive a single rapid intravenous injection of approximately 185 MBq 5 mCi of 68GaGa-ELI421 followed by a saline flush. Whole-body static or dynamic PET scans will be performed using this agent. Additionally, PSMA PET imaging will be done according to routine clinical practice. This study involves only one treatment arm focusing on dual PET imaging with ELI421 and PSMA for prostate cancer. During the study, participants will be monitored for adverse events on the first three days after injection. Researchers will measure lesion uptake, absorbed radiation dose, and diagnostic performance on Day 1. Safety assessments include physical exams, vital signs, laboratory tests, and ECG. Participation may last up to the study completion date in December 2026, with all procedures aimed at evaluating the imaging agents safety and diagnostic value.

Researchers are evaluating the safety and effectiveness of combining Adebrelimab and SHR-8068 with chemoradiotherapy as a perioperative treatment for patients with locally advanced rectal cancer that can be surgically removed. This phase IIIII clinical trial aims to improve outcomes for this condition by comparing different treatment combinations. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. and involves multiple centers with randomized group assignments. Participants will be assigned to one of three treatment groups one receiving radiotherapy combined with Adebrelimab, SHR-8068, and chemotherapy another receiving radiotherapy with Adebrelimab and chemotherapy and a third receiving radiotherapy plus chemotherapy alone. These treatments are given around the time of surgery to assess their impact on the cancer. Dosing and specific schedules are managed as part of the clinical protocol. During the study, participants will undergo evaluations including pathological complete response rates at 12 months and additional measures such as clinical complete response, disease-free survival, event-free survival, tumor regression grade, surgical outcomes, hospital stay length, overall survival, and perioperative mortality over 60 months. Researchers will monitor safety, treatment effects, and surgical outcomes through regular assessments. The total study duration extends until November 2035, allowing for long-term follow-up of participants.