Prula-cel for autoimmune diseases: a phase 1 study
Treatments studied
Part of Bones, joints & muscles, Brain & nervous system, Heart & circulation, Immune system & allergy, Kidney & urinary, Skin, Women’s health & pregnancy clinical trials.
This trial tests a new treatment called prulacabtagene leucel (prula-cel), which is a type of immune cell therapy (CAR T-cells) for people with certain autoimmune diseases. It aims to see if it can reset the immune system and reduce disease activity in conditions like lupus, scleroderma, vasculitis, or myositis.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must have one of these autoimmune diseases: lupus with kidney inflammation, lupus affecting other organs, systemic sclerosis, vasculitis (GPA or MPA), or myositis or stiff person syndrome.
- Standard treatments for your condition must have failed or not worked well enough. This means you've tried at least two different medicines (like steroids, mycophenolate, or cyclophosphamide) and they didn't help enough.
- Your kidneys need to be working fairly well (a blood test shows a certain level of function) and you must be able to breathe on your own without extra oxygen, with oxygen levels above 93% on room air.
- You cannot have had any prior gene therapy or genetically modified cell therapy (like CAR T-cells).
- You must not have a serious active infection, recent organ transplant, or certain heart conditions (like heart failure or a recent heart attack).
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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