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 phasessingle and multiple ascending dosesand 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 safety and effectiveness of tumor infiltrating lymphocyte TIL therapy in adults with advanced solid tumors. This early-phase study involves patients who have either relapsed, metastasized, or have primary solid tumors and have failed standard treatments or have no standard options available. The study focuses on patients with measurable tumors and a life expectancy of more than three months. Participants receive an infusion of their own expanded TILs, ranging from 1 billion to 50 billion cells, administered intravenously over 30 to 120 minutes. Before the infusion, patients undergo a non-myeloablative lymphodepletion treatment with hydroxychloroquine a single 600 mg dose and cyclophosphamide. The therapy is given after tumor tissue or malignant fluid is collected for TIL expansion. Throughout the study, participants are closely monitored for adverse events over six months and assessed for tumor response, disease control, duration of response, progression-free survival, and overall survival for up to 36 months. Quality of life changes are also evaluated during this period. Participants must adhere to follow-up visits and assessments to track treatment effects and safety over time.

This prospective, multicenter, observational cohort study focuses on patients with allergic bronchopulmonary aspergillosis. The aim is to evaluate the efficacy and safety of biological agents used in these patients across multiple participating centers. The study observes how biological agents perform in the treatment of allergic bronchopulmonary aspergillosis while also assessing their safety.

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 patients 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 1x109 to 5x1010 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 2x108 to 1x1010 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 evaluating the safety and effectiveness of a gene-edited tumor infiltrating lymphocyte therapy called GC203 TIL in patients with pancreatic ductal adenocarcinoma. This early-phase study involves patients who have undergone tumor resection to produce the gene-edited TILs and have failed standard treatment options. The study aims to better understand how this therapy may work in this patient population. Participants receive an infusion of GC203 TILs, which are expanded from their tumor tissue, after receiving a non-myeloablative lymphodepletion treatment that includes a single dose of hydroxychloroquine 600 mg and cyclophosphamide. The infused dose ranges from 5x108 to 1.5x1010 cells with a 20% variability. The treatment is given intravenously following the preparative lymphodepletion regimen. Throughout the study, participants are closely monitored for adverse events over six months and evaluated for tumor responses, disease control, duration of response, progression-free survival, and overall survival for up to 36 months. Follow-up includes regular assessments to track treatment effects and safety. The total participation period spans several years to capture both immediate and long-term outcomes of the therapy.

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.