Tests CAR T-cell therapy in adults with relapsed myasthenia gravis
Tests donor-made CAR T-cells targeting CD19 and BCMA in adults with myasthenia gravis.
Plain-language title generated from the registry record
Registry title: UCAR T-cell Therapy Targeting CD19/BCMA in Patients With r/r Myasthenia Gravis
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Where in China
- The first affiliated hospital of medical college of zhejiang universityHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT06933563
- Record updated
- 18 April 2025
- Original description
This is an open label, single-site, dose-escalation study in up to 18 participants with relapsed or refractory Myasthenia gravis. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.Read full original descriptionShow less
A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Myasthenia Gravis
This is an open label, single-site, dose-escalation study in up to 18 participants with relapsed or refractory Myasthenia gravis. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.
Inclusion: Age ≥ 18 years; Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood; Patients with relapsed refractory myasthenia gravis (MG) who have positive abnormal antibodies, the total score of MG-ADL ≥5, and the eye muscle score < 50% of the total score; It is classified as Grade II-IV according to the 2020 MGFA diagnostic criteria; Specific requirements include: i. Receiving standardized treatment with at least one immunosuppressant for more than 1 year, and having any of the following malcontrolled conditions: 1) persistent inability to affect daily life; 2) Aggravation of MG symptoms and/or crisis episodes occur despite standard treatment; 3) Inability to tolerate immunosuppressive therapy. ii. plasma exchange or maintenance of intravenous immunoglobulin therapy is required; Functional requirements for major organs are as follows:; The bone marrow function needs to meet: a Neutrophil count ≥ 1.5× 10 \^ 9/L; b. Hemoglobin ≥90g/L: c. Platelets ≥ 80 × 10 \^ 9/L; Liver function: ALT ≤ 3 × UL; AST ≤ 3×ULN# Total bilirubin ≤ 2.0 ×ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN); Renal function: creatinine clearance rate (CrCl) ≥ 30 ml/min(Cockcroft/Gault formula, excluding acute CrCl decline caused by the disease itself); Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating; Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion: Subjects who had participated in other clinical trials within 3 months prior to enrollment; Subjects with a history of severe drug allergies or allergic tendencies; Presence or suspicion of uncontrolled or treatment-required fungal,bacterial, viral, or other infections; Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis); Subjects with insufficient cardiac function; History of malignancy within five years; Subjects with end-stage renal failure; Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer higher than the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing; Subjects with psychiatric disorders and severe cognitive impairments; Subjects who have used immunosuppressive agents or biologics with therapeutic effects on the disease within five half-life before enrollment; Subjects with congenital immunoglobulin deficiencies; Pregnant women or women planning to conceive; Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.