Zheng Zhou Shi

This research aims to evaluate the effectiveness and safety of a combination treatment using Selinexor, Pegaspargase, and Dexamethasone for patients with early-stage NKT-cell lymphoma. The study is designed as a Phase 1 and Phase 2 clinical trial and focuses on improving local disease control and overall prognosis in this specific type of lymphoma. Patients receive an oral regimen combining Selinexor, Pegaspargase, and Dexamethasone. Selinexor works by inhibiting nuclear export proteins that are overexpressed in malignant tumor cells, including viral mRNA such as EBV. This treatment is combined with sequential radiotherapy to potentially enhance outcomes. The study monitors the responses to this combined therapy in early-stage lymphoma. Participants will be involved in regular assessments to track tumor response and overall health. The primary outcome measured is the complete response rate CRR based on tumor volume reduction, evaluated up to 36 months from randomization. Safety and treatment effects will be closely monitored during the trial period, which runs from September 2024 through December 2026.

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

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 the pharmacokinetic properties and safety of a drug called AHB-137 injection in adults aged 18 to 65 years who have mild to moderate liver dysfunction as well as those with normal liver function. This study is designed as a Phase 1 clinical trial to better understand how the drug behaves in these different groups and to assess any potential safety concerns. It is sponsored by Ausper Biopharma Co., Ltd. and involves participants with chronic hepatitis B. Participants receive a single subcutaneous injection of AHB-137. The study includes two groups of participants with liver dysfunction classified as Child-Pugh A and Child-Pugh B, along with matched groups of participants with normal liver function. The groups are studied in parallel, and the trial compares how the drug is processed in their bodies. The dosing involves only one administration, and the study duration extends up to 29 days for monitoring. During the study, participants undergo various assessments to measure pharmacokinetic parameters, including peak concentration and drug exposure over time area under the curve up to day 29. Safety indicators are also monitored throughout this period. Participants may have physical exams, laboratory tests, and other procedures to ensure safety and collect data on the drugs behavior. The total participation time lasts up to 29 days following the injection.

Researchers are studying the safety and effectiveness of GT801 injection in adults who have relapsed or refractory CD19-positive B-cell blood cancers, including acute lymphoblastic leukemia, chronic lymphocytic leukemia, non-Hodgkins lymphoma, and autoimmune hemolytic anemia. This early phase 1 study aims to understand how well the treatment works and its side effects in this group of patients. Participants will receive the GT801 injection as the study treatment. The study focuses on one group receiving this intervention. The treatment schedule and dosing details are not specified, but safety and response to the treatment will be monitored over a period of time, including up to 12 months after infusion. During the study, participants will be closely monitored for side effects and treatment responses through various assessments. Researchers will measure the proportion of participants experiencing dose-limiting toxicity within 28 days and track adverse events up to 3 months after infusion. They will also evaluate overall response rates, duration of response, progression-free survival, and other outcome measures related to both the blood cancers and autoimmune hemolytic anemia for up to 12 months. The study includes regular follow-up visits and evaluations to gather this information.

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

Researchers are evaluating the efficacy and safety of a drug called B007 in adults with pemphigus, a condition characterized by blistering of the skin and mucous membranes. This Phase IIIII clinical trial is designed to understand how well B007 works to achieve remission with minimal treatment and to monitor its safety in this patient population. Participants will receive B007 through subcutaneous injections administered on days 1 and 15. The study measures include the proportion of patients achieving complete remission, partial remission, changes in the Pemphigus Disease Area Index PDAI, frequency of disease relapses, duration of response, and incidence of treatment-emergent adverse events. The treatment period and follow-up assessments extend up to approximately one year. During the trial, participants will be closely monitored through scheduled visits to assess disease activity and treatment response. Outcomes such as remission rates and relapse frequency will be tracked, along with safety evaluations for any adverse effects. The total participation duration includes about one year of observation after treatment initiation to fully capture treatment effects and safety data.

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are studying the safety, tolerability, and preliminary effectiveness of GO306 Recombinant Oncolytic Vaccinia Virus Injection in patients with advanced solid tumors who have not responded to standard treatments. This open-label, non-randomized trial uses a dose-escalation design to explore the best dose and safety profile. The trial has two parts first to find the maximum tolerated dose and then to evaluate repeated doses in specific tumor types. The study involves two phases Part 1 uses a 33 design with single intratumoral or intracavitary injections of GO306 at low, medium, and high doses to determine the recommended dose for further study. Part 2 involves multiple doses of GO306 given weekly or every two weeks at the recommended dose to evaluate safety and explore preliminary effectiveness in selected tumor types. Participants will receive treatment injections and undergo monitoring for side effects, pharmacokinetics, viral shedding, and immune response. Researchers will assess adverse events, dose-limiting toxicities, and treatment responses using imaging. Follow-up evaluations include laboratory tests and immunological assessments. Study participation may last months, with some outcomes monitored up to five years after treatment.