Cheng De Shi

Researchers are evaluating TQB2934, a special antibody designed to treat multiple myeloma, a type of malignant plasma cell tumor. TQB2934 is a double-specific antibody that binds to both the CD3 receptor on T cells and the BCMA antigen on cancerous plasma cells. This binding helps recruit and activate T cells to attack and kill the cancer cells. The study is a Phase 1 clinical trial focusing on the safety and pharmacokinetics of this treatment in adults with multiple myeloma. The treatment involves subcutaneous injections of TQB2934. The antibody works by activating T cells to release substances that kill BCMA-positive target cells. The study monitors participants over time to assess how the drug is processed in the body, including measures like peak drug concentration and elimination half-life within 120 hours after administration. The trial also tracks adverse events for up to 24 months. Participants will undergo various laboratory tests and assessments to meet study requirements and monitor their health throughout the trial. Researchers will evaluate pharmacokinetics, including peak time, drug concentration, and clearance, as well as safety by recording any adverse events. The study includes careful monitoring of participants' condition and treatment responses, with follow-up lasting up to two years to ensure comprehensive safety data collection.

Researchers are evaluating the safety and effectiveness of combining TQ05105 Tablets and TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis. This open, single-arm, multi-center clinical trial is conducted in Phase Ib/II to study this combination treatment in adults with this condition. The goal is to find the best dose and assess how well the treatment works, including measuring spleen size reduction. The study treatment includes TQ05105 Tablets, which inhibit Janus kinase 1 and 2, and TQB3617 Capsules, which inhibit Bromodomain and Extra-Terminal proteins. Participants receive these drugs together, but specific dosing schedules are not detailed in the provided information. The study includes multiple phases to evaluate safety and dose levels for up to two years. Participants will undergo various assessments, including measuring spleen volume changes and determining maximal tolerated doses. The main outcomes include the recommended phase II dose and spleen volume reduction over 24 weeks and up to two years. Safety monitoring and evaluation of symptom scores are also part of the follow-up during the study period, helping researchers understand the treatment impact and tolerability.

Researchers are conducting a Phase Ib/II clinical trial to assess the safety, effectiveness, and how the body processes TQB3909 tablets combined with azacitidine in adults with myeloid malignancies, which include diseases like acute myeloid leukemia and myelodysplastic syndromes. The study aims to evaluate how well patients tolerate this combination and its impact on their condition. Participants will receive TQB3909, a protein inhibitor, along with azacitidine, a cytidine nucleoside analogue. The treatment is administered as tablets, and the study is open-label and multi-center. The trial focuses on monitoring adverse events for up to 24 weeks and measuring remission rates within 4 weeks after starting treatment. During the study, participants will undergo various evaluations to track safety and treatment response, including monitoring for side effects and laboratory tests. Researchers will record the incidence and severity of any adverse events and assess the rate of complete remission or remission with partial blood recovery. Participants must be adults aged 18 years or older and will be followed closely for up to 24 weeks to ensure safety and effectiveness of the treatment combination.

Researchers are evaluating the safety and effectiveness of TQB3909 tablets in patients who have recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial focuses on patients diagnosed according to specific criteria and aims to understand how well this treatment works and how safe it is for this population. The study investigates TQB3909, a drug designed to inhibit the B-cell lymphoma-2 (BCL-2) protein. Participants will receive TQB3909 tablets as part of the treatment regimen. The trial includes monitoring for side effects and disease response over time. The study will measure the recommended phase II dose and assess remission rates through evaluations conducted up to 34 months. Participants will be involved in assessments that include monitoring for adverse events, serious adverse events, and abnormal laboratory results. These will be tracked for up to 34 months to evaluate safety and treatment impact. The study also includes imaging tests for measurable lesions and pregnancy testing for women of childbearing potential. Overall, the trial may last up to nearly three years, with ongoing safety and effectiveness evaluations throughout.

Researchers are evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are evaluating the effectiveness of JNJ-95597528 compared to a placebo in adults with moderate to severe atopic dermatitis, a chronic skin condition. This Phase 2b study aims to assess how well JNJ-95597528 works in improving symptoms in participants who have had the condition for at least one year and meet specific disease severity criteria. JNJ-95597528 and placebo will both be given by subcutaneous injection. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will receive their assigned treatment and be monitored throughout the study to evaluate the drug's impact on their skin condition. Participants will be involved in scheduled visits where their eczema severity will be assessed using the Eczema Area and Severity Index (EASI) among other measures. The primary outcome is the proportion of participants achieving a 75% improvement in EASI at Week 12. Safety and adherence to the treatment plan will also be monitored during the study period.

Researchers are evaluating the effect of TQB3473 tablets, a selective Spleen tyrosine kinase (Syk) inhibitor, compared to placebo in adults with primary immune thrombocytopenia (ITP) who have previously received standard corticosteroid therapy and failed or relapsed after at least one standard ITP treatment. This Phase III randomized, double-blind, placebo-controlled study aims to demonstrate that TQB3473 improves the sustained platelet response rate in this population. The study includes a treatment period followed by a safety follow-up period. Participants are randomly assigned to receive either TQB3473 tablets or a matching placebo. The treatment duration includes a 24-week randomized double-blind period during which platelet counts and durable response rates are closely monitored. The placebo contains no active substance, allowing comparison of effects with the active treatment. After the treatment phase, participants enter a safety follow-up period to monitor ongoing effects and adverse events. During the study, participants will have multiple assessments including platelet count measurements to evaluate response to treatment. Researchers will track durable platelet response defined by platelet counts of 50×10^9/L or higher during weeks 14 to 24. Safety evaluations and monitoring for adverse reactions will occur throughout the treatment and follow-up periods. The total participation time covers screening, treatment, and follow-up phases, ensuring comprehensive evaluation of treatment effects and safety.

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are evaluating the effectiveness and safety of efgartigimod given through intravenous infusion in adults with primary immune thrombocytopenia (ITP), a condition characterized by low platelet counts. This Phase 3 trial includes participants who have had ITP for over a year and have previously received treatments like corticosteroids or immunoglobulins but had insufficient responses. The study aims to measure disease control by tracking the number of weeks during which platelet counts remain at or above 50 x 10^9/L over a 24-week treatment period. After a screening period of up to 2 weeks, participants are randomly assigned in a 2:1 ratio to receive either efgartigimod IV or a placebo IV during a 24-week double-blinded treatment period. Following this, all participants enter a 52-week open-label treatment phase where everyone receives efgartigimod IV. Those who complete this phase may continue for an additional 52 weeks in a second open-label treatment period. After finishing these treatment phases, participants undergo an approximately 8-week follow-up period without the study drug. Throughout the study, participants will have their platelet counts regularly monitored to assess the extent of disease control. Researchers will also evaluate safety and monitor participants for any medical conditions that might affect the study results or their well-being. The total duration of participation can be up to 138 weeks, including screening, treatment, and follow-up periods.

This research investigates patients with relapsed or refractory acute myeloid leukemia (R/R AML) who have specific mutations in the IDH1 or IDH2 genes. The trial aims to evaluate how well HMPL-306 works, its safety, and how the body processes it compared to salvage chemotherapy. This is a phase III, multicenter, randomized, open-label study involving two separate patient groups based on their IDH mutation type, with each group analyzed independently. Participants are randomly assigned to one of two treatment groups. The experimental group receives HMPL-306 monotherapy starting with 250 mg daily in the first 28-day cycle, then 150 mg daily from the second cycle onward. The control group receives one of four salvage chemotherapy regimens chosen by the investigator based on the patient's condition, including two intensive regimens and two less intensive regimens. Treatments continue in 28-day cycles until treatment failure or other defined endpoints occur. Patients undergo pre-screening to confirm mutation status and are grouped accordingly. Throughout the study, patients undergo comprehensive evaluations including bone marrow biopsies, quality of life assessments, and efficacy assessments based on leukemia response criteria at regular intervals. Safety is closely monitored through adverse event tracking and laboratory tests. Follow-up periods include end-of-treatment visits, safety observation, event-free survival monitoring every 8 weeks, and overall survival follow-up until death or study end. The total study duration depends on achieving a target number of survival events in each cohort.