Clinical Research Directory

GC012F Injection in Refractory Idiopathic Inflammatory Myopathy

This is a single-arm, open-label, early exploratory clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with refractory idiopathic inflammatory myopathy and to assess the pharmacokinetic and pharmacodynamic profiles. This study consists of screening period, apheresis period, baseline period, lymphodepleting preconditioning period, pre-infusion evaluation period, CAR-T cell infusion period and follow-up period. Eligible subjects will undergo apheresis and receive infusion following the manufacture of the CAR-T product. Subjects will receive lymphodepleting preconditioning before CAR-T cell infusion and will be assessed before infusion. If the criteria for cell infusion are met, CAR-T cell infusion will be performed and the infusion dose in the same group or subsequent treatment groups may be adjusted according to the safety and clinical response. A total of 1 dose group will be set for CAR-T cell infusion dose in this study: 3 × 10\^5/kg. Approximately 12 subjects are planned to be enrolled. Subjects will be monitored for dose-limiting toxicity (DLT) within 28 days following the infusion of GC012F Injection. For the first 3 patients receiving infusions of GC012F, 3 additional patients will be included in this cohort if no more than 1/3 of the patients experience DLTs at a given dose level. If 2/3 or more DLTs occur at this dose level, a spare dose of 2.0 × 10\^5/kg or 1.0 × 10\^5/kg may be administered to subsequent subjects following discussion between the investigator and the partner. If no more than 1 out of the first 6 subjects experiences a DLT, 6 additional subjects will be enrolled. Once 2 subjects experience DLTs, the investigator and the partner will discuss and decide whether to use a spare dose group of 2.0×10\^5/kg or 1.0×10\^5/kg. After the first 3 subjects have all completed the 28-day DLT observation period, the Safety Monitoring Committee (SMC) will conduct an assessment based on clinical safety and pharmacokinetic data (if available). Subsequently, the SMC may, depending on the safety profile and study progress, request an increased frequency of safety committee assessments and reviews. After completing the DLT observation period for all subjects in this dose group, all clinical study data collected during the DLT observation period for this dose group, especially safety data, will be assessed, and whether to add new subjects to this dose group and whether to explore a different dose group will be decided upon discussion between the investigator and the partner. Following CAR-T cell infusion, subjects will be followed for safety, cell proliferation and survival, and efficacy until the subject withdraws from the study and refuses subsequent follow-up, or dies, or withdraws consent, or is lost to follow-up, whichever occurs first.

Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases

This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10/IL15 CAR-NK cells in patients with refractory/relapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.

OM336 in Seropositive Autoimmune Diseases

An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. OM336 is administered subcutaneously in ascending dose cohorts.

Safety Study of CC312 in Autoimmune Disease Patients

This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy. CC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the "biopharmaceutical version" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy. The study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A "3+3" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.

Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy

The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs. Despite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation. The assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy. Through this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.

Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases

A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.

GC012F in Patients With Autoimmune Diseases

This is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic (PD) profiles.

A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases

This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases.