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

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Engineered immune cells take on autoimmune diseases in early trial

NCT ID NCT07095075

Disease control Sponsor: Nanjing Legend Biotech Co. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This early-phase study is testing a new cell therapy called LUCAR-DKS1 in 36 adults with relapsed or refractory autoimmune diseases like lupus. Participants receive their own modified NK cells after a short chemotherapy prep. The main goals are to check safety, find the right dose, and see how long the cells last in the body.

What this could mean

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

Active substance
LUCAR-DKS1 NK cells (a type of immune cell therapy)
What this could lead to
If it works, this could point toward a new way to control severe autoimmune diseases that haven't responded to other treatments.
What could go wrong
This is a very early, small trial focused on safety, not effectiveness. The therapy may not work, and there are risks of serious side effects from the cells or the pre-treatment chemotherapy.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 36 people

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

Started

Oct 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 70 years

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. Subjects voluntary agreement to provide written informed consent. 2. Aged 18 to 70 years, either sex. 3. Clinical laboratory values meet screening criteria. 4. Positive test for CD19 and/ or BCMA SLE: * Meets at least 1 classification criteria≥6 months for SLE. * At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive. * Fulfill relapsed/refractory SLE conditions. AAV: * Meets the 2022 ACR/EULAR classification criteria for AAV. * Positive test for anti-MPO or p-ANCA or anti-PR3 or anti-MPO antibodies at screening. * Fulfill relapsed/refractory AAV conditions. SSc: * Meets the 2013 ACR/EULAR classification criteria for SSc. * At screening, mRSS is higher than 10. * Fulfill relapsed/refractory SSc conditions. IIM: * Meets 2017 EULAR/ACR classification criteria for IIM. * Positive test for myositis-associated antibodies or myositis-specific antibodies at screening. * Fulfill relapsed/refractory IIM conditions. SjS： * Meets the 2016 ACR/EULAR diagnostic criteria for SjS. * Positive test for anti-SSA and/or anti-SSB antibodies at screening. * Fulfill relapsed/refractory SjS conditions. Exclusion Criteria: 1. Active infections such as hepatitis and tuberculosis. 2. Other autoimmune diseases. 3. Serious underlying diseases such as tumor, uncontrolled diabetes. 4. Female subjects who were pregnant, breastfeeding. 5. Those with a history of major organ transplantation. 6. Have received autologous cell therapy of any target before.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for ANCA associated vasculitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autoimmune disease granulomatosis with polyangiitis idiopathic inflammatory myopathy Sjogren syndrome systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Relapsed/refractory autoimmune diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    RECRUITING

    Hefei, Anhui, 230036, China

  • The First Affiliated Hospital of Wenzhou Medical University

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, 325015, China

  • The Third The People's Hospital of BengBu

    NOT_YET_RECRUITING

    Bengbu, Anhui, 233000, China

More trials for these conditions

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