RecruitingEarly Phase 1NCT07337785

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

Clinical Study on the Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Neurological Autoimmune Diseases

Sponsor

Daishi Tian

Enrollment

36 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsing or Refractory Multiple Sclerosis (MS)Myasthenia Gravis (MG)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Autoimmune Encephalitis (AE)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cutting-edge cell therapy called UCAR-T — immune cells engineered to target two proteins (CD19 and BCMA) — in people with serious autoimmune diseases affecting the nervous system, such as multiple sclerosis, myasthenia gravis, or neuromyelitis optica. These modified cells come from donors rather than the patient themselves. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with a neurological autoimmune disease (such as relapsing-remitting MS, neuromyelitis optica, or myasthenia gravis) that has not responded adequately to standard treatments - Your heart, liver, kidney, and blood counts meet minimum health thresholds - You are not pregnant and agree to use effective contraception **You may NOT be eligible if...** - You have severe or uncontrolled organ problems - You have an active serious infection - You are pregnant or breastfeeding - Your disease is stable and responding well to current treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD19/BCMA-targeted CAR-T cells

Participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single intravenous infusion of CD19/BCMA-targeted CAR-T cells (RD06-05) at dose of 1 × 10\^7 CAR+ T cells/kg (Additional dose levels will be determined by safety, PK/PD, and preliminary efficacy).

DRUGLymphodepleting Conditioning

From Day -5 to Day -3 prior to cell infusion (Day 0), subjects will receive chemotherapy preconditioning based on the "Fludarabine + Cyclophosphamide" (FC regimen). The recommended preconditioning regimen is as follows: Fludarabine: 30 mg/m² per day, once daily for 3 consecutive days; Cyclophosphamide: 300 mg/m² per day, once daily for 3 consecutive days;