Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Engineered immune cells take on autoimmune diseases

NCT ID NCT07155369

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new treatment for people with lupus or scleroderma that hasn't improved with standard care. The treatment uses specially engineered immune cells from a healthy donor (called universal CAR T-cells) to target and destroy faulty immune cells. The goal is to control the disease and reduce symptoms, not to cure it. The trial involves 18 participants and will monitor safety and effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
UCAR-T cells (universal donor CAR T-cells targeting CD19 and BCMA) with cyclophosphamide and fludarabine
What this could lead to
If successful, this could offer a new treatment option for people with severe lupus or scleroderma that hasn't responded to other therapies, potentially putting the disease into remission.
What could go wrong
This is a very early, small trial with only 18 participants, so results may not apply to everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years old (inclusive), regardless of gender. 2. Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry. 3. Adequate hepatic, renal and bone marrow function. 4. Participants with relapsed or refractory autoimmune diseases, Including SLE or SSc. Exclusion Criteria: 1. Participants with a history of severe drug allergies or allergic constitutions. 2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections. 3. Participants with insufficient cardiac function. 4. Participants with congenital immunoglobulin deficiencies. 5. History of malignancy within five years.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Systemic lupus erythematosus are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.