Engineered immune cells take on autoimmune disease

NCT ID NCT06544330

Ongoing Disease control Sponsor: Synthekine Source: ClinicalTrials.gov ↗

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.

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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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