Testing a new immune cell therapy for autoimmune diseases

Plain-English translation of NCT07085104 on ClinicalTrials.gov ↗ · Source last updated September 2026 · Translation generated August 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 one of the first studies in humans to test ALLO-329, a new type of immune cell therapy designed to treat autoimmune diseases like lupus, inflammatory myopathy, and systemic sclerosis. Researchers believe this medication works by targeting specific immune cells that cause these diseases. The study will evaluate whether the treatment is safe and whether it helps reduce disease symptoms.

Current treatments for these autoimmune diseases don't work well enough for everyone, and some patients continue to suffer despite taking standard medications. This trial explores whether this new treatment approach might help people whose disease has not responded adequately to existing therapies.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have been diagnosed with lupus, inflammatory muscle disease, or systemic sclerosis with active symptoms
your disease has not improved enough despite taking at least one standard immunosuppressive medication for at least 3 months
you have adequate heart, lung, liver, and blood cell function
you are willing to use effective contraception for at least 6–12 months after treatment
you are able to attend regular clinic visits and follow all study procedures

You likely don't qualify if…

you have an active infection (bacterial, fungal, or viral) that requires treatment
you have had cancer in the past 5 years (except certain skin cancers or low-risk prostate cancer)
you have received prior CAR T cell therapy or CD19- or CD70-targeted treatments
you have severe heart, lung, or liver disease or uncontrolled diabetes or thyroid problems
you have a condition that prevents you from receiving blood transfusions if needed

What participation looks like

You will receive a preparation regimen (which may include chemotherapy medications to prepare your body) followed by an infusion of the engineered immune cells. Depending on which group you are assigned to, you may receive one or two chemotherapy drugs before the cell infusion, or the cells alone. You will have frequent clinic visits, blood tests, and monitoring appointments to check your safety and how well the treatment is working. The study will track you for an extended period to make sure there are no delayed side effects.

AI-generated summary from trial data · Aug 3, 2026 · Not medical advice

Testing a new immune cell therapy for autoimmune diseases

What is this trial?

Do you qualify?

What participation looks like

Trial locations