Testing immune cells from healthy donors to treat severe autoimmune diseases

Plain-English translation of NCT07115745 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This is an early-stage trial testing BMS-986515, a treatment made from healthy donor immune cells that have been specially engineered in the laboratory. The cells are designed to target and calm down the overactive immune cells causing your autoimmune disease. The trial will check whether this treatment is safe and whether it helps reduce your symptoms.

Severe autoimmune diseases like lupus, scleroderma, myositis, and rheumatoid arthritis can be devastating and don't always respond to current medications. This new treatment offers a different approach — using the immune system itself to fight back — for people who have exhausted standard options.

Do you qualify?

You likely qualify if…

you have been diagnosed with lupus, inflammatory muscle disease, scleroderma, or rheumatoid arthritis that meets specific medical criteria
your disease is severe and has not improved despite taking steroids and other standard immune-suppressing drugs
you have signs that your disease is still active at the time you join the trial
you have specific antibodies or markers in your blood that confirm your diagnosis
you are at least 18 years old and in generally stable health

You likely don't qualify if…

you are pregnant, nursing, or planning to become pregnant
you have an active infection, hepatitis B or C, or HIV
you have a history of cancer
you have had CAR-T cell therapy before
you have severe heart, lung, kidney, or liver problems, or uncontrolled high blood pressure in your lungs

What participation looks like

You will have screening visits to confirm your diagnosis and check that you're healthy enough to participate. If you qualify, you'll receive an infusion of the engineered immune cells, likely at a hospital or clinic. You'll then have follow-up visits to check how you're doing, how well the treatment is working, and whether you experience any side effects. The trial involves blood tests and regular check-ins to monitor your progress over time.

AI-generated summary from trial data · Jul 20, 2026 · Not medical advice

Trial locations(28 sites)

United States

Brigham And Womens Hospital, Boston, Massachusetts

Duke University, Durham, North Carolina

Australia

Local Institution - 0007, Camperdown, New South Wales

Local Institution - 0008, Brisbane, Queensland

Local Institution - 0013, Clayton, Victoria