Clin2
NCT06375993Possibly a fitEnrolling by invitation

Prula-cel for autoimmune diseases: a phase 1 study

Lupus NephritisAutoimmune DiseasesSystemic Sclerosis (SSc)Systemic Lupus Erythematosus (SLE)ANCA-Associated Vasculitis (AAV)Idiopathic Inflammatory MyopathiesStiff Person Syndrome

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.

Phase
Phase 1
Enrollment
180 people
Ages
18 years to 80 years
Study type
Interventional

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).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

Similar studies

Other trials that look related to this one.

NCT07364396Not yet recruiting· Phase 1/Phase 2
A new cell therapy for severe lupus

This trial tests a new treatment called CRC01, made from your own cells, for people with severe lupus that hasn't improved with standard medications. The goal is to see if it can safely control the disease and reduce symptoms.

NCT06121297Recruiting· Phase 1/Phase 2
CABA-201 for active lupus

This trial tests a new treatment called CABA-201, which is a type of immune cell therapy (CAR T cells) for people with active lupus. The goal is to see if it's safe and can help control lupus symptoms.

Orange, California
NCT06581198Recruiting· Phase 2
CAR-T cell therapy for lupus or lupus nephritis

This trial tests a new CAR-T cell treatment called rapcabtagene autoleucel for people with active lupus or lupus nephritis that hasn't improved with at least two standard therapies. It aims to reduce disease activity and may offer a new option for hard-to-treat cases.

Birmingham, Alabama
NCT06277427Recruiting
CAR-T cell therapy for refractory vasculitis and lupus nephritis

This trial tests a new type of cell therapy called CAR-T cells that target BCMA (a protein on certain immune cells) for people with two autoimmune diseases: ANCA-associated vasculitis and lupus nephritis. It is for patients whose disease has not responded to standard treatments or has come back after initial improvement.

Wuhan, Hubei
NCT06420154Not yet recruiting· Early Phase 1
CAR-T cell therapy for autoimmune diseases

This trial tests if a special immune cell therapy (CAR-T) can help people with certain autoimmune diseases like lupus, Sjogren's syndrome, scleroderma, myositis, vasculitis, or antiphospholipid syndrome that haven't improved with standard treatments. It is a very early phase study to check safety and effectiveness.

Wenzhou, Zhejiang
NCT06010472Recruiting· Early Phase 1
Car-NK cell therapy for lupus

This trial tests a new immune cell therapy (CAR NK cells) for people with moderate to severe lupus that hasn't responded well to standard treatments. The therapy targets a protein called CD19 on certain immune cells to calm the overactive immune system.

Shanghai

Hear when a new Lupus Nephritis trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.