Quan Zhou Shi

Researchers are evaluating the efficacy and safety of a drug called B007 compared to Cyclosporin in treating Primary Membranous Nephropathy, a kidney condition confirmed by biopsy. This study is a multicenter, randomized, controlled, open-label trial in phase II/III, focusing on patients aged 18 to 80 years with certain kidney function levels and proteinuria. Participants will receive either B007 via subcutaneous injections on days 1 and 15 or oral Cyclosporin capsules dosed at 3.5 mg per kg per day. The study includes screening to confirm eligibility, treatment administration, and monitoring for approximately two years to evaluate overall remission rates. Throughout the trial, participants will be monitored with laboratory tests to meet study standards and ensure safety. Researchers will assess kidney function, protein levels in urine, and remission rates over about two years. Safety will be followed closely, including checking for allergies, infections, and adherence to the treatment protocol.

Researchers are evaluating the effectiveness of Equecabtagene Autoleucel Injection, a CAR-T cell therapy targeting BCMA, compared to standard therapy in adults with lenalidomide-refractory relapsed or refractory multiple myeloma (RRMM) who have received 1-2 prior treatment lines. Multiple myeloma is a cancer of plasma cells causing bone and marrow damage. This phase III, multicenter, randomized, controlled, open-label study aims to assess the progression-free survival benefit of eque-cel versus standard therapy over an approximately 6-year period. Participants are randomly assigned to receive either a single dose of Equecabtagene Autoleucel Injection (1.0x10^6 CAR-T cells per kg) or standard therapy regimens including combinations of Daratumumab, Pomalidomide, Bortezomib, and Dexamethasone with specified dosing schedules. After enrollment and randomization, patients receive their assigned treatment and enter a follow-up phase to monitor safety, evaluate efficacy, and study pharmacokinetics in the experimental arm. Throughout the study, participants undergo screening with informed consent, regular safety assessments, efficacy evaluations, and laboratory monitoring. The primary outcome is progression-free survival assessed by an independent review committee for up to 5 years after randomization. Participants are monitored for organ function, disease progression, and adverse effects, with total study participation lasting about six years to fully capture long-term outcomes and safety.

Researchers are evaluating an automated anesthesia system that uses reinforcement learning during painless gastrointestinal endoscopy in adults aged 18 to 65 years with ASA physical status I-II. The trial aims to compare the safety and performance of anesthesia controlled by an AI model versus anesthesia controlled by experienced anesthesiologists. The primary question is whether the AI system can safely and effectively manage anesthesia without being inferior to traditional professional care. Participants will receive anesthesia induced with ciprofol during the gastrointestinal endoscopy procedure. In one group, the anesthesia will be controlled by the AI model, while in the other group, it will be managed by experienced anesthesiologists. The procedure is expected to last less than one hour. Before the procedure, participants must fast for at least 8 hours and refrain from drinking water for 2 hours after taking intestinal purgatives. Throughout the procedure, researchers will monitor the incidence of hypoxemia as a key safety outcome. Participants will be closely observed during anesthesia to assess the effectiveness and safety of the AI-controlled system compared to the traditional method. The study focuses on anesthesia induction performance and safety during the endoscopy procedure.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of HB0017 Injection in adults with moderate to severe plaque psoriasis. Participants must have chronic plaque psoriasis lasting at least 6 months, with significant disease severity measured by PASI and body surface area affected. Participants are assigned to one of three groups: receiving HB0017 injection every 4 weeks after initial doses at weeks 0, 1, 2, 4, and 8; HB0017 injection every 8 weeks after the same initial dosing schedule; or placebo injections following the initial doses and then switching to HB0017 every 4 weeks. Treatment is administered via biological injections according to these schedules. Throughout the study, researchers will monitor participants to determine the proportion achieving a 75% improvement in the Psoriasis Area Severity Index (PASI 75) and the proportion reaching a static Physician Global Assessment (sPGA) score of 0 or 1 at week 12. Safety, immune response, drug levels, and effects on the disease will also be assessed. The study includes adults aged 18 to 75 years and tracks treatment outcomes and adverse events over the duration of the trial.