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Engineered immune cells take on autoimmune disease

NCT ID NCT06544330

Disease control Sponsor: Synthekine Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new treatment for people with severe lupus or scleroderma that hasn't responded to standard therapies. The treatment involves taking a patient's own immune cells, modifying them to target and destroy faulty immune cells, and giving them back along with a supporting drug. The main goal is to see if the treatment is safe and tolerable in 48 participants.

What this could mean

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

Active substance
A combination of two treatments: SYNCAR-001 (a patient's own immune cells modified to target and destroy faulty immune cells) and STK-009 (a drug that helps those modified cells survive and work longer).
What this could lead to
If it works, this could point toward a new way to control severe autoimmune diseases like lupus and scleroderma without lifelong medication.
What could go wrong
This is a very early (phase 1) and small trial (48 people) focused on safety. The treatment may cause serious side effects, and it is not yet known if it will effectively control the disease.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

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

Started

Apr 2025

Expected to finish

Apr 2041

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 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.

General Inclusion Criteria: Age ≥18 years at screening. SLE Inclusion Criteria: 1. Clinical diagnosis of SLE according to the 2019 European League Rheumatism EULAR/ACR classification criteria. 2. Subject must be positive for at least one of the following at screening: Anti-dsDNA (above the upper limit of normal \[ULN\]); or anti-Sm (above the ULN); or anti-Chromatin (above the ULN). 3. Subjects with active, severe, non-renal SLE or subjects with active proliferative LN SSc Inclusion Criteria: 1. Classified as SSc according to the ACR/EULAR classification criteria. 2. Diffuse cutaneous SSc (dcSSc) or SSc-associated ILD (SSc-ILD; significant or progressive). General Exclusion Criteria: 1. History of or active central nervous system manifestations of autoimmune disease. 2. Prior treatment with anti-CD19 adoptive T cell therapy, or any prior gene therapy product (e.g., CAR T cell therapy). SLE Exclusion Criteria: 1. Rapidly progressive glomerulonephritis. 2. End stage renal failure requiring dialysis or most recent renal biopsy with purely chronic lesions (Class III\[C\], IV-S\[C\], or IV-G\[C\]) if isolated renal disease. SSc Exclusion Criteria: 1. FVC \<50% of predicted or DLCO \<40% of predicted. 2. Pulmonary arterial hypertension (PAH) requiring PAH-specific treatment. Other protocol-defined criteria apply.

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Lupus nephritis Systemic lupus erythematosus Systemic sclerosis

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Feinstein Institutes for Medical Research

    Manhasset, New York, 11030, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

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