Universal CD19/BCMA CAR T-cell therapy for relapsed or refractory neurological autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-site, dose-escalation study will enroll up to 12 adults with relapsed or refractory neurological autoimmune diseases (NMOSD, myasthenia gravis, multiple sclerosis, CIDP, or autoimmune encephalitis) who have CD19 or BCMA-positive B cells. Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single intravenous infusion of allogeneic (universal) CD19/BCMA CAR T-cells. Safety, tolerability, and early signs of clinical effect will be monitored closely with scheduled visits and laboratory testing. An interim analysis is planned when participants complete the 90-day visit after CAR T-cell infusion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
* Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).
* 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 Criteria:

* Subjects with a history of severe drug allergies or allergic tendencies.
* History of malignancy within five years.
* Subjects with insufficient cardiac function.
* Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>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.
* Pregnant women or women planning to conceive.

Where it's running

• Tianjin Huanhu Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Jialing Wu
• Email: wywjl2009@hotmail.com
• Phone: 86-18622271026

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.