Zheng Zhou Shi

Researchers are evaluating the safety and effectiveness of a combined oral treatment using Selinexor, Pegaspargase, and Dexamethasone for patients with early-stage NK/T-cell lymphoma. This study focuses on patients with stage I or II disease and aims to improve disease control and overall prognosis by targeting nuclear export proteins involved in the cancer's growth. Selinexor may inhibit certain viral mRNAs linked to this lymphoma, offering a promising treatment approach. Participants receive the combination of Selinexor, Pegaspargase, and Dexamethasone as an oral regimen. This treatment may be followed by sequential radiotherapy as part of the approach to manage the lymphoma. The study evaluates this regimen's potential as a preferred choice for early NK/T-cell lymphoma by monitoring tumor response over time. During the study, patients are closely monitored for tumor volume reduction up to 36 months after randomization. Assessments include clinical evaluations and laboratory tests to track safety and treatment effects. Researchers also require participants to use contraception during the study and monitor for any adverse effects to ensure patient safety throughout the trial period.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

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 safety and effectiveness of GT801 Injection in adults aged 18 to 75 years who have relapsed or refractory CD19-positive B-cell blood cancers or autoimmune hemolytic anemia. The study includes patients with specific types of B-cell leukemias and lymphomas, and those with autoimmune hemolytic anemia, all of whom have experienced disease progression after at least two prior treatments. This early phase 1 clinical trial aims to better understand how well the GT801 Injection works and its safety profile in these patient groups. Participants will receive GT801 Injection as the treatment under study. The study focuses on adults with confirmed CD19 positivity (for blood cancers) and certain treatment histories, including specific requirements for prior therapies and time intervals since last treatments. The treatment will be administered with careful monitoring throughout the study period, which lasts up to 12 months. This includes observing any dose-limiting toxicities within the first 28 days and tracking adverse events from the initial infusion through the entire treatment duration. During the study, participants will be closely monitored with regular assessments to evaluate treatment effects and safety. Researchers will measure the proportion of patients experiencing dose-limiting toxicities early in treatment and the frequency and severity of any adverse events over 12 months. Participants' overall health status, blood tests, and other clinical evaluations will be conducted as needed to ensure safety and to gather comprehensive data on treatment impact. The study’s total duration and follow-up are designed to capture both short- and long-term effects of GT801 Injection in this patient population.

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are evaluating the safety and effectiveness of B007 in adult subjects diagnosed with pemphigus, a condition characterized by specific clinical signs. This Phase II/III clinical study aims to determine how well B007 works in treating this disease, including those newly diagnosed or experiencing a relapse. Participants receive B007 through subcutaneous injections given on day 1 and day 15. The study includes varying doses of B007 to assess treatment outcomes over time. This controlled dosing schedule allows researchers to monitor responses to the medication closely. During the study, researchers will track the proportion of subjects who achieve complete remission with minimal treatment by approximately 36 weeks. Participants are expected to follow the study protocol, which includes regular assessments to monitor treatment effects and safety. Long-term monitoring will help determine the success of B007 in managing pemphigus symptoms.

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of GO306 Recombinant Oncolytic Vaccinia Virus Injection in adults with advanced solid tumors that have not responded to standard treatments. This early stage Phase 1 study uses a single-arm, open-label, dose-escalation design and includes two parts. Part 1 focuses on determining the maximum tolerated dose (MTD) through single doses, while Part 2 explores repeated doses in specific tumor types to identify the recommended Phase 2 dose (RP2D) and optimal dosing schedule. In Part 1, participants receive a single intratumoral or intracavitary injection of GO306 at escalating dose levels: low (3.0 x 10^7 PFU), medium (3.0 x 10^8 PFU), or high (1.0 x 10^9 PFU). Each dose level includes 3 subjects. Part 2 involves multiple doses of GO306 at the RP2D level given weekly or every two weeks to about 20 subjects with specific tumor types. The study monitors pharmacokinetics, viral shedding, immunogenicity, and immunological changes related to GO306 treatment. Participants will undergo evaluations including safety assessments for adverse events up to 6 months after treatment, dose-limiting toxicity monitoring for 21 days post-first injection, and pharmacodynamic assessments. Tumor lesions are evaluated by imaging per RECIST 1.1 criteria. Laboratory tests and performance status are assessed before treatment to confirm eligibility. Follow-up includes monitoring serious adverse events and tolerability, with an expected survival time of at least 3 months. The study duration and procedures ensure careful observation of treatment effects and participant safety throughout.

Researchers are evaluating the use of Hanlikang and BTK inhibitors in treating patients newly diagnosed with mantle cell lymphoma. This open-label, single-arm, multicenter, prospective clinical study focuses on adults aged 18 to 70 years who have confirmed mantle cell lymphoma and an expected survival time longer than six months. The study aims to assess the progression-free survival over two years in this patient group. The treatment plan varies based on age. Patients younger than 65 receive six cycles of R-BAP chemotherapy combined with oral ibrutinib, with effectiveness checked every two cycles and side effects monitored. After chemotherapy, these patients continue oral ibrutinib for one year, with evaluations every three months. Patients aged 65 and older receive four cycles of R-BAP, followed by four cycles of rituximab consolidation therapy, then one year of oral zanubrutinib, with similar monitoring schedules. Participants will have regular assessments during treatment, including checks of blood counts, liver and kidney function, and lymphoma lesions to monitor treatment response and safety. Researchers will evaluate progression-free survival over two years. Safety and adverse events will be closely recorded throughout the study. Participants are expected to cooperate with follow-up visits and use contraception if of childbearing potential during the study period.