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Engineered immune cells take aim at Hard-to-Treat autoimmune diseases

NCT ID NCT07144462

Disease control Sponsor: Neukio Biotherapeutics (Shanghai) Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental cell therapy called NEUK203-215 in adults aged 18-65 with severe autoimmune diseases like lupus or scleroderma that have not responded to other treatments. The therapy uses immune cells from a healthy donor, engineered to target and attack faulty immune cells. Participants also receive chemotherapy drugs to prepare their bodies for the cell infusion. The study focuses on safety and tolerability, with a small group of 8 people.

What this could mean

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

Active substance
a healthy donor allogeneic CD19/BCMA-targeted CAR-NK cell product called NEUK203-215, given with chemotherapy drugs fludarabine and cyclophosphamide
What this could lead to
If successful, this could point toward a new treatment option for people with severe autoimmune diseases that have not responded to standard therapies.
What could go wrong
This is a very early, small trial with only 8 participants, so results may not apply broadly. There are risks of side effects from the cell therapy and chemotherapy, including infections and allergic reactions.

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 8 people

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

Started

Sep 2025

Expected to finish

Jan 2027

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 65 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\) Has provided signed informed consent; 2) Is aged 18-65 years ; 3)Adequate functional reserve of vital organs 4) Has a confirmed diagnosis of systemic lupus erythematosus, diffuse systemic sclerosis, inflammatory myopathy, or autoimmune bullous dermatosis. Exclusion Criteria: * 1\) Requires dialysis treatment. 2) History of severe drug hypersensitivity. 3) Active infection requiring systemic therapy or suspected uncontrolled infection. 4\) Within 6 months before screening, any of the following cardiovascular events: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac disease. 5\) Malignancy within the past 5 years. 6) Clinically significant chronic or intermittent bleeding within 60 days before the screening visit. 7\) Prior solid-organ (e.g., heart, lung, kidney, liver) or hematopoietic stem-cell/bone-marrow transplantation. 8\) At screening: positive HBsAg and/or HBcAb with HBV DNA detectable or above the lower limit of quantitation; positive HCV antibody with HCV RNA detectable or above the lower limit of quantitation; positive HIV antibody; positive syphilis test (except biologic false-positive results). 9\) Major surgery within 4 weeks before screening. 10) Live or live-attenuated vaccine received within 4 weeks before screening. 11) Uncontrolled concurrent medical conditions. 12) Documented history of neurologic or psychiatric disorders. 13) Any other factor that, in the investigator's judgment, could require premature withdrawal from the study.

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Conditions

The condition(s) this trial relates to.

autoimmune bullous skin disease autoimmune disease diffuse cutaneous systemic sclerosis inclusion body myositis systemic lupus erythematosus

As listed by the trial registrant

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

Autoimmune

How to take part

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

  1. The places running it

    1 site. 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

  • Shanghai Changzheng Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200131, China

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