Ji Lin Shi

Researchers are evaluating the use of BCMA-targeted positron emission tomographycomputed tomography PETCT scans in patients with multiple myeloma and related plasma cell disorders. This prospective, multicenter diagnostic imaging study aims to visualize and measure BCMA expression throughout the body, helping to detect active disease and its variations. The study focuses on how this imaging method may provide valuable clinical information across different disease states. Participants will receive the 68Ga-labeled BCMA PETCT imaging through an intravenous injection of a BCMA-targeted radiotracer followed by a whole-body scan following a standardized protocol. Imaging results will be compared with biopsy findings when possible to assess accuracy. The study will also explore relationships between PETCT findings and other clinical, laboratory, and imaging markers, including minimal residual disease assessments. Some participants will have blood samples taken to measure circulating soluble BCMA levels, providing additional biological context. During the study, participants will undergo the PETCT imaging and may have biopsies and blood tests as part of assessments. Researchers will analyze imaging findings alongside clinical and laboratory data to understand disease burden and response. Safety of the radiotracer will be monitored for up to 30 days after injection. Follow-up will assess changes in imaging over time and the impact on clinical management. The study is expected to last until December 2027 and includes adults aged 18 to 80 years.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are conducting a Phase IbIIa clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of IMC-003 injection in adults with pulmonary arterial hypertension PAH who are already receiving background therapy. The trial focuses on patients with WHO Group 1 PAH, including several subtypes such as idiopathic, heritable, and drug-induced PAH. Participants must have symptomatic PAH with specific functional classifications and hemodynamic criteria confirmed by right heart catheterization. Participants will be randomly assigned to receive either IMC-003 or a placebo, injected eight times every three weeks while continuing their stable background PAH treatment. Background therapy includes approved drugs such as endothelin receptor antagonists, PDE-5 inhibitors, sGC stimulators, and prostacyclin analogs. The study is double-blinded and parallel in design, and treatment will last for 24 weeks in both phases of the trial. During the study, participants will undergo various assessments including heart MRI, 6-minute walk distance tests, and blood tests measuring NT-proBNP and other hemodynamic parameters. Researchers will monitor safety, disease progression, and treatment effects throughout the 24-week treatment period. The study also includes ongoing evaluation of symptoms, functional classification, and laboratory markers to understand the impact of IMC-003 in this patient population.

Researchers are evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigators choice of BRR2 regimen in patients with relapsed or refractory non-germinal center B-cell-like non-GCB diffuse large B-cell lymphoma DLBCL. This open-label, randomized controlled Phase II clinical study aims to provide new treatment options for patients who have experienced relapse or resistance after prior therapies, including at least one anti-CD20 antibody-containing regimen. Participants are randomly assigned to receive either Rocbrutinib at 200 mg orally once daily until disease progression or unacceptable toxicity, or the investigators choice of combination therapy consisting of Bendamustine and Rituximab BR or Rituximab plus Lenalidomide R2. The BR regimen involves six 28-day cycles of Bendamustine 90 mgm2 IV infusion on Days 1 and 2 and Rituximab 375 mgm2 IV infusion on Day 1 of each cycle, while the R2 regimen includes Rituximab with Lenalidomide at 20 mg orally on Days 1 to 21 of each cycle. Participants will undergo regular assessments including evaluations of overall response rate, complete remission rate, progression-free survival, overall survival, duration and time to response, and safety monitoring up to 24 months, with some outcomes followed for up to five years. Safety is assessed from the first dose until 28 days after the last dose. The total participation duration depends on treatment response and follow-up schedules, with careful monitoring throughout the study to track treatment effects and adverse events.

Researchers are evaluating a new medicine called YL201 compared to the standard chemotherapy chosen by doctors in people with locally advanced or metastatic esophageal squamous cell carcinoma who have stopped responding to first-line treatment. The goal is to see if YL201 works better and is safer. The study is a large, randomized phase III trial involving multiple hospitals and also investigates how YL201 is processed in the body, immune reactions it might cause, and whether certain biological markers can predict its effects. Participants will be assigned to one of two groups one group receives YL201 alone, given as an intravenous infusion on the first day of each 3-week cycle. The other group receives a chemotherapy drug chosen by their doctor, which may be paclitaxel, docetaxel, or irinotecan, each given intravenously on specific schedules every 3 weeks. The study treatment continues as planned, with monitoring throughout the treatment period. During the study, participants will undergo regular evaluations including scans and laboratory tests to measure how well the treatments are working and to monitor side effects. The main outcome researchers will track is overall survival for up to about 36 months. They will also assess progression-free survival, response rates, duration of response, and adverse events during this time. The study will last until the end of 2028, with ongoing monitoring and data collection.

Researchers are studying SKB500 in people with advanced solid tumors to understand its safety, how the body processes it, immune response, and effects against tumors. This Phase I clinical trial includes multiple stages dose-escalation, dose-expansion, and indication-expansion phases to evaluate these aspects in detail. Participants will receive SKB500 through an intravenous infusion once every three weeks. The study will monitor how well participants tolerate the treatment, any side effects, and how the drug behaves in the body across the different study phases. During the study, participants will undergo regular assessments to track adverse events, dose-limiting toxicities, and antitumor activity up to three years. Evaluations include measuring drug levels over time, immune responses, and overall safety. Participants will be followed closely throughout the treatment and observation periods to gather comprehensive data.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Researchers are studying the safety and effectiveness of AHB-137 injection in adults with chronic hepatitis B CHB who have low levels of hepatitis B surface antigen HBsAg. This Phase 2, open-label, multicenter study aims to evaluate how well AHB-137 works alongside or without nucleostide analogue NA therapy in this population. Participants receive AHB-137 injections, with some also receiving NA therapy while others do not. The study includes different parts where participants may be treated with AHB-137 combined with NA therapy or AHB-137 alone. Treatment and monitoring continue through multiple weeks, including assessments after stopping all CHB treatments. During the study, participants undergo various tests to measure viral markers such as HBsAg, HBV DNA, and other related indicators, along with quality of life questionnaires. Researchers track the presence of anti-drug antibodies, drug resistance, and treatment-emergent adverse events for up to 60 weeks, including a key evaluation at 24 weeks after stopping all CHB treatment to assess persistent viral suppression.

Researchers are evaluating the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

Researchers are evaluating the safety of hydronidone capsules in patients who have chronic hepatitis B infection with liver fibrosis or fatty liver disease with liver fibrosis. This open-label, single-arm Phase 2 study aims to collect information on any adverse effects that may occur during treatment. Approximately 200 participants will be involved, focusing on conditions related to liver fibrosis, including compensated cirrhosis, diagnosed through histology, imaging, or laboratory markers. All participants will receive hydronidone capsules taken orally three times daily, with three capsules per dose, totaling 270 mg each day. The medication is taken half an hour before meals for 28 days. This study does not include a comparison group and is designed to observe the effects of the drug over this fixed treatment period. During the study, participants will be monitored for any adverse events that occur following drug administration. Safety assessments will be conducted throughout the 28-day treatment period. Participants will be required to use effective contraception during the study and for six months after treatment if applicable. The study aims to gather detailed safety data to better understand the tolerability of hydronidone capsules in this patient population.