Testing a new immune cell therapy for severe autoimmune diseases

Plain-English translation of NCT07085104 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated June 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 human studies of ALLO-329, a new type of therapy that uses specially engineered immune cells to help calm down an overactive immune system. Researchers want to see if this medication is safe and whether it can help people with autoimmune diseases like lupus, inflammatory myopathy, or systemic sclerosis who haven't improved with standard treatments.

Current treatments for these serious autoimmune diseases don't work well enough for everyone, and some patients continue to suffer despite using multiple medications. This trial explores whether this new approach to resetting the immune system could offer relief for patients who haven't had success with existing options.

Do you qualify?

You likely qualify if…

you are between 18 and 70 years old
you have been diagnosed with systemic lupus erythematosus, idiopathic inflammatory myopathy, or systemic sclerosis that is still active
your autoimmune disease has not improved enough despite taking standard treatment for at least 3 months
you have adequate heart, lung, liver, and blood cell function
you are willing to use reliable birth control for at least 6 to 12 months after the treatment
you can attend regular study visits and follow the treatment plan

You likely don't qualify if…

you have an active infection (bacterial, fungal, or viral) requiring treatment
you have been diagnosed with cancer in the past 5 years (except for certain skin cancers)
you have received previous treatments targeting CD19, CD70, or any prior engineered cell therapy
you have serious heart, lung, or liver disease beyond what is related to your autoimmune condition
you have a primary immune deficiency or are unwilling to participate in long-term safety monitoring

What participation looks like

Participants will receive the new immune cell therapy after a preparation regimen (which may include chemotherapy medications to help prepare the body). Depending on which group you're assigned to, you may receive one or two chemotherapy drugs before the cell therapy infusion, or the cell therapy alone. You will need to attend regular clinic visits for monitoring, blood tests, and assessments over an extended period to ensure the treatment is safe and to measure how well it works.

AI-generated summary from trial data · Jun 26, 2026 · Not medical advice

Testing a new immune cell therapy for severe autoimmune diseases

What is this trial?

Do you qualify?

What participation looks like

Trial locations