ClinicalTrials.gov record NCT06939166

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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 Neurological Autoimmune Diseases

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhaseEarly phase 1A very early study, usually in a small number of people, to learn how the body handles a treatment. It is not designed to show whether the treatment works.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label early phase 1 dose-escalation study will give a single infusion of universal CD19/BCMA CAR T‑cells to up to 12 adults with relapsed or refractory neurological autoimmune diseases. The CAR T‑cell infusion is given after a short lymphodepleting regimen of fludarabine and cyclophosphamide. The study primarily records dose‑limiting toxicities and adverse events; some disease-specific outcomes are followed for up to 24 months.

What it is studying. The study tests the safety and preliminary efficacy of a single intravenous infusion of universal allogeneic CAR T‑cells that target CD19 and BCMA in adults with relapsed or refractory neurological autoimmune diseases.

What the researchers hope to learn. To measure dose‑limiting toxicities and overall adverse events after UCAR infusion and to collect preliminary disease‑specific outcome data (EDSS, mRS, QMG, MG‑ADL, INCAT, CASE) over time to inform safety and early efficacy signals.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • UCAR T-cell

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is an investigator-initiated trial to evaluate the safety and efficacy of universal CD19/BCMA CAR T-cells in Relapsed or Refractory Neurological Autoimmune Diseases. Study intervention consists of a single infusion of universal CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when participants finish the visit 90 days after CAR T-cell infusion.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After giving informed consent, participants will receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by a single intravenous infusion of universal CD19/BCMA CAR T-cells. They will undergo close safety monitoring with blood tests and clinical checks; dose‑limiting toxicities are assessed within 28 days and adverse events are followed up to 90 days. Participants will have regular follow-up visits and disease-specific assessments (for example EDSS, modified Rankin Scale, QMG, MG‑ADL, INCAT, CASE) for up to 24 months. Women of childbearing potential will have an HCG test before enrollment and must follow the contraception/abstinence requirements for at least 6 months after treatment.

How the study is structured. Interventional, open‑label, single‑group, early Phase 1 dose‑escalation study. Each participant receives lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by one IV infusion of UCAR CD19/BCMA T‑cells. There is no masking. Safety is closely monitored (dose‑limiting toxicities assessed in the first 28 days; adverse events tracked to 90 days) and some disease outcomes are followed up to 24 months. Planned enrollment is up to 12 participants.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

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Important dates

Study start
Jun 17, 2025
Primary completion
April 2026 (estimated)
Study completion
October 2027 (estimated)
Target enrollment
12 participants (estimated)
Last updated on registry
Dec 15, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Tianjin Huanhu Hospital
Principal investigator
Jialing Wu, Principal Investigator
Tianjin Huanhu Hospital
Collaborators
  • Shanghai Xiniao Biotech Co., Ltd.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

open label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
dose-escalation
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
relapsed or refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
CAR T
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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