Tolerability

Researchers are evaluating the safety and tolerability of GenSci134, a drug given by subcutaneous injection, in healthy adult volunteers and adults with Growth Hormone Deficiency (AGHD). This study has two parts: the first part involves healthy volunteers in two phases—single and multiple ascending doses—and the second part includes AGHD patients receiving a single ascending dose. The trial aims to assess safety, how the drug acts in the body (pharmacokinetics and pharmacodynamics), immune responses, and other exploratory effects. In the first part, Phase Ia tests single doses of GenSci134 in healthy adult males across seven dose groups with placebo and active controls. Phase Ib evaluates multiple doses in healthy adult males and females in three dose groups. The second part, Phase Ic, studies two dose groups of AGHD patients receiving single doses of GenSci134 compared to active controls. The active comparator is recombinant human growth hormone injection given daily for 28 days. Treatments are given subcutaneously, and the study is randomized and double-blind. Participants will undergo safety assessments including monitoring adverse events for up to three months after dosing. Researchers will collect data on drug absorption, effects on the body, immune response, and tolerability. Healthy volunteers and AGHD patients will be monitored through scheduled visits involving laboratory tests and evaluations to track any side effects and responses to the treatments. The total participation duration varies by study phase and dosing schedule.

Researchers are evaluating the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis (ABPA), a condition that often affects people with severe bronchial asthma. The study follows guidelines from ISHAM for ABPA diagnosis and treatment, aiming to understand how biologics can impact this condition. This is a prospective, multicenter observational cohort study sponsored by Qianfoshan Hospital. Participants receive standard medical treatment consisting of oral prednisone with a tapering dose over several weeks, with or without oral voriconazole. Some patients also receive biological agents combined with this standard therapy for at least four months, following GINA2025 guidelines. The biologics are given alongside existing asthma treatments, such as inhaled corticosteroids and long-acting beta-agonists. The study compares groups receiving biologics plus standard treatment versus standard treatment alone. During the study, researchers monitor participants for one to two years, assessing the number of exacerbations, hospitalizations, time to first exacerbation, remission rates, glucocorticoid use, asthma control, and various immune markers such as serum IgE and eosinophil counts. Safety and overall mortality are also tracked. This extensive follow-up includes measuring treatment responses at eight weeks and ongoing assessments to evaluate long-term effects and disease control.

Researchers are conducting a long-term follow-up trial for patients who previously received imlifidase treatment before kidney transplantation. This trial includes patients from a prior study (PAES trial) who were transplanted with a new kidney, either after imlifidase treatment or standard care medication. The aim is to continue evaluating kidney function and safety over time, fulfilling European Medicines Agency requirements. Participants include those treated with imlifidase, an enzyme that breaks down certain antibodies to prevent kidney rejection, or those who received the best available treatment as per standard transplantation routines. The study follows patients for up to five years after transplantation to collect ongoing data. During the trial, patients will be monitored regularly for kidney graft survival, kidney function tests like estimated Glomerular Filtration Rate and creatinine levels, antibody levels, rejection episodes, treatment of rejections, adverse events, and life participation changes. The trial tracks these outcomes at 2, 3, and 5 years post-transplantation to understand long-term efficacy and safety, with participation lasting up to five years.

The FARE Patient Registry is a prospective observational study focused on collecting detailed health and basic information about individuals living with food allergies. Its purpose is to encourage open sharing of de-identified data and to support participation in clinical trials, ultimately aiming to advance scientific discoveries related to food allergy causes and contributing factors. This registry does not involve any treatment or interventions but gathers real-world experiences from participants with food allergies. It serves as a platform for the food allergy community to contribute data that can help researchers understand the extent and etiology of food allergies. Participants provide their health information and experiences, which are stored in the registry for ongoing research use. The main outcome measured is the creation of a registry that characterizes food allergies and factors influencing their development. The study is observational, with no interventions, and participation can continue until the study end date in August 2027.

Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte (TIL) therapy using GC101 TIL in patients with advanced breast cancer. This early phase 1 clinical study focuses on patients who have either primary, relapsed, or metastatic breast cancer and have failed standard treatments or have no available standard options. The study aims to understand how this therapy works in controlling disease and its side effects. The treatment involves collecting a patient's own TILs from tumor biopsies or resections, expanding them in the lab, and then infusing between 1 billion to 50 billion cells intravenously. Before the TIL infusion, patients receive a non-myeloablative lymphodepletion regimen that includes a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The infusion itself takes about 30 to 120 minutes. Participants will be monitored for adverse events over six months and followed up to 36 months to assess tumor response, disease control, duration of response, progression-free survival, and overall survival. Quality of life changes will also be tracked. Throughout the study, patients undergo blood tests, tumor evaluations, and regular follow-up visits to measure safety and treatment effects. The total study duration may extend up to three years for outcome assessments.

Researchers are studying the safety and effectiveness of tumor infiltrating lymphocyte (TIL) therapy for patients with advanced hepatobiliary and pancreatic cancers. This early phase 1 study involves patients who have primary, relapsed, or metastasized liver or pancreatic cancers. The goal is to evaluate how well this treatment works and its impact on disease progression and survival over up to 36 months. Participants receive an infusion of their own expanded TILs, ranging from 1x10^9 to 5x10^10 cells, after a non-myeloablative lymphodepletion treatment that includes a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The TILs are prepared from tumor tissue or malignant fluids collected through biopsy or surgery. The infusion is given intravenously over 30 to 120 minutes. During the study, participants will be monitored for up to 36 months with regular assessments of adverse events, tumor response, disease control, duration of response, progression-free survival, and overall survival. Researchers will also evaluate changes in quality of life. Patients must be able to follow the visit schedule and attend follow-ups to assess treatment effects and safety over time.

Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma, a serious form of skin cancer. This early phase study focuses on giving patients TILs grown from their own tumor samples after a mild lymphodepletion treatment using hydroxychloroquine and cyclophosphamide. The goal is to better understand how this treatment affects the disease and patient outcomes. Participants receive an infusion of 1 billion to 50 billion autologous TILs through an intravenous line over 30 to 120 minutes. Before the infusion, patients undergo a non-myeloablative lymphodepletion regimen that includes a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The treatment is given after tumor cells are collected and expanded in the lab. There are no placebo groups or masking in this study. During the study, patients will be closely monitored for adverse events for up to six months and followed for treatment responses, disease control, progression-free survival, and overall survival for up to three years. Quality of life changes will also be tracked. Participants will have regular lab tests and clinical assessments to evaluate safety and treatment effects. The total participation duration varies depending on individual follow-up.

Researchers are evaluating the safety and effectiveness of signal switch receptor modified tumor-infiltrating lymphocytes (GC201 TIL) in women with advanced gynecologic tumors. This early-phase study focuses on patients who have primary, relapsed, or metastasized gynecologic cancers and have not responded to standard treatments or have no standard options available. The modified TILs are designed to enhance immune activity by converting suppressive signals in the tumor environment into persistent T cell activation. Participants receive autologous TILs that have been gene-modified to express either TGF-b2 or PD-1 signal switch receptors. These cells are expanded in the lab and then infused intravenously in doses ranging from 2x10^8 to 1x10^10 cells. Before infusion, patients undergo a non-myeloablative lymphodepletion treatment using hydroxychloroquine (single 600 mg dose) and cyclophosphamide. The infusion lasts between 30 to 120 minutes. Throughout the study, participants will be monitored for adverse events up to 6 months and evaluated for response rates, disease control, response duration, progression-free survival, and overall survival up to 36 months. Quality of life changes will also be assessed. Participants must attend follow-up visits and meet laboratory and clinical requirements. The total participation duration spans several years to thoroughly assess treatment impact and safety.

Researchers are investigating the safety and effectiveness of a gene-edited tumor infiltrating lymphocyte therapy called GC203 TIL for patients with pancreatic ductal adenocarcinoma. This early-phase study focuses on patients who have undergone tumor resection and have failed standard treatments, aiming to evaluate how this treatment works in this serious form of pancreatic cancer. Participants will receive an infusion of expanded gene-edited GC203 TILs, ranging from 5x10^8 to 1.5x10^10 cells, following a non-myeloablative lymphodepletion treatment that includes a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The infusion is given intravenously after the lymphodepletion process. The study monitors patients for adverse events over six months and tracks various measures of tumor response and survival up to 36 months. Throughout the study, participants will undergo evaluations including blood tests and tumor assessments to monitor safety and treatment effects. Researchers will examine adverse events and tumor response rates, as well as progression-free and overall survival. Participants are expected to follow scheduled visits and assessments, with continuous monitoring for safety and treatment outcomes during the study period.

Researchers are evaluating the safety and tolerability of single and multiple increasing doses of GenSci098 given under the skin in patients with active thyroid eye disease (TED) related to Graves' disease. This Phase 1 clinical trial aims to understand how the body processes this drug and to monitor for any side effects. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. Participants will receive subcutaneous injections of GenSci098 at one of five dose levels (15mg, 45mg, 90mg, 180mg, or 270mg) or a matching placebo. The study includes two parts: a single ascending dose (SAD) phase where participants receive one dose, and a multiple ascending dose (MAD) phase where participants receive repeated doses. The study uses a randomized and quadruple-blind design to compare GenSci098 and placebo. During the study, participants will be monitored for adverse events through physical exams, vital signs, laboratory tests, and ECGs over periods of up to 169 days in the SAD part and 281 days in the MAD part. Researchers will also measure how GenSci098 moves through and acts in the body, including antibody responses. Participants will be asked to comply with study treatments and assessments until the study ends.