Clinical Research Directory

Plasma Exchange in Pediatric Autoimmune Encephalitis

The aim of the study will be to compare the efficacy of daily plasma exchange (PLEX) versus alternate-day PLEX in achieving a favorable functional outcome in children with autoimmune encephalitis. The study population will be divided into two groups, the first group will perform PLEX on consecutive days and the second one will perform it every other day. Then, A Favorable functional outcome measure defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor at the end of the sessions to determine which method has superior efficacy in treatment of autoimmune encephalitis.

A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults

The POLARIS study is designed to evaluate how well efgartigimod PH20 SC may work (called "efficacy") and how safe it is for people diagnosed with Autoimmune Encephalitis (AIE). The study consists of 4 parts: in part A participants will receive efgartigimod SC; in part B, participants will be randomized to receive either efgartigimod SC or placebo; in part C, participants who completed part B will receive efgartigimod SC; in part D, participants who completed part C will be observed after their last dose of efgartigimod SC. If AIE symptoms return, efgartigimod SC treatment may be restarted during this time. The maximum overall study duration for participants is up to 3 years. More information can be found in clinicaltrials.argenx.com/polaris

OPM- MEG in Non-immune And iMmune-medIated Neurological Disease

Over the past 20 years, doctors have gotten much better at spotting and treating brain conditions caused by the immune system attacking the body. These include illnesses like autoimmune encephalitis, ADEM, and multiple sclerosis. But even with better treatments, many patients-especially children-still struggle with long-term problems. Standard brain scans and tests often miss important issues like memory problems, emotional difficulties, trouble sleeping, and challenges with social behaviour. Early research using a special brain imaging technique (called MEG) has shown changes in brain networks that seem to be linked to poor memory. This study will use a new, advanced version of MEG that works even with very young children (as young as 2 years old). The goal is to better understand how these brain conditions affect children, compare them with other types of brain illness, and eventually use this technology to help predict outcomes and discover new ways to track brain health.

Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Refractory Autoimmune Encephalitis and Autoimmune Cerebellitis

This is a multicenter, single-arm, continuous, prospective, interventional registry study designed to systematically evaluate the efficacy and safety of low-dose blinatumomab in patients with antibody-mediated refractory autoimmune encephalitis (AE) and autoimmune cerebellitis. Eligible participants will be patients with a confirmed diagnosis of refractory AE or autoimmune cerebellitis who have provided written informed consent. All enrolled patients will receive blinatumomab treatment according to a unified protocol, consisting of two cycles: Cycle 1 (Week 1): Continuous intravenous infusion at 9 µg/day for 5 consecutive days (total dose: 45 µg). Cycle 2 (Week 3): Continuous intravenous infusion at 9 µg/day for 5 consecutive days (total dose: 45 µg). If there is no improvement in the modified Rankin Scale (mRS) score at Week 3 and the proportion of peripheral blood B cells (CD3-/CD19+) remains \>1%, the dose may be optimized to 15 µg/m²/day (maximum 28 µg/day). During the study, all patients will undergo regular follow-up visits to collect data on clinical symptoms, functional scores, immunological biomarkers, and adverse events, to comprehensively assess the efficacy and safety of the treatment. This study uses a non-randomized, open-label design with no blinding or control group.

Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.

This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to "3+3" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of recurrent/refractory antibody-mediated neurological autoimmune diseases.

CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases

This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders. In this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data. For each indication, 6 to 9 subjects will be enrolled, with a total of 24 to 36 subjects planned for enrollment in the entire study.

Is [18F]-DPA-714 PET a Good Marker of Neuroinflammation in Autoimmune Encephalitis?

This study aims to evaluate the effectiveness of \[18F\]-DPA-714 PET imaging in detecting neuroimmune activity in patients with autoimmune encephalitis (AE). The primary objective is to compare \[18F\]-DPA-714 binding in AE patients to healthy controls.