Recruiting EARLY_PHASE1 Neuromyelitis Optica Spectrum Disorders

New treatment option for Neuromyelitis Optica Spectrum Disorders

Official title Universal Chimeric Antigen Receptor T-Cell (UCAR T-cell) Therapy Targeting CD19/B Cell Maturation Antigen (CD19/BCMA) in Patients With r/r Neurological Autoimmune Diseases

ClinicalTrials.gov ID: NCT06939166

What this study is testing

What is UCAR T-cell?

UCAR T-cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuromyelitis optica spectrum disorders.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥ 18 years.
  • Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
  • people with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG)...
  • Female people of childbearing potential and male people with partners of childbearing potential must use medically approved contraception or...
  • Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.

You likely can't join if

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

The study team makes the final eligibility decision.

Where it's taking place

  • Tianjin, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.