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Can engineered immune cells tame autoimmune disease?

NCT ID NCT06318533

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This early-phase trial is testing whether a single infusion of engineered immune cells, called CAR NK cells, can safely and effectively treat people with moderate to severe autoimmune diseases that have not improved with standard treatment. The study will enroll 15 adults and will first assess safety, then look at how well the cells control the disease and how long they last in the body. The approach involves a short course of chemotherapy before the cell infusion to help the cells engraft.

What this could mean

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

Active substance
Chimeric antigen receptor (CAR) NK cells, given after a short course of chemotherapy (fludarabine and cyclophosphamide)
What this could lead to
If successful, this could lead to a new treatment option for people with autoimmune diseases that haven't responded to standard therapies, potentially resetting the immune system.
What could go wrong
This is a very early, small trial (15 people) focused mainly on safety. The treatment may not work, and there are risks of side effects from the chemotherapy and the cell infusion, including immune 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 15 people

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

Started

Mar 2024

Expected to finish

Mar 2027

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 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 voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures 2. Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases 3. Age: ≥ 18 years old and ≤ 70 years old, male or female 4. Subjects with estimated survival \> 12 weeks 5. Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) 6. ECOG performance ≤ 2 7. Left ventricular ejection fraction (LVEF) ≥ 45% 8. Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment Exclusion Criteria: 1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions 2. Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes 3. Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections 4. Subjects with grade III or IV heart failure (NYHA classification) 5. History of epilepsy or other central nervous system (CNS) diseases 6. History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors 7. Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism 8. Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months 9. Females who are pregnant, lactating, or planning a pregnancy within six months 10. Subjects who have received other clinical trial treatment within 3 months 11. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome

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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.

How to take part

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

  1. The places running it

    2 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

  • Affiliated Hospital of Jiangsu University

    RECRUITING

    Zhenjiang, Jiangsu, 212001, China

  • Jiangsu University Affiliated Hospital

    RECRUITING

    Zhenjiang, Jiangsu, 212001, China

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