A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
This research study is testing a new treatment called ALLO-329 for adults with severe autoimmune diseases, including lupus (with or without kidney problems), a type of muscle inflammation, and systemic sclerosis (scleroderma). This is the very first time this specific treatment will be given to people. The main goals are to make sure the treatment is safe and that people can tolerate it well. Doctors also want to see if there are any early signs that it helps improve patients' conditions. This study will help decide the best way to give the treatment if it continues into future research. It's an important step in finding new ways to manage these challenging conditions.
At a glance
What is this study about?
You might be reading this because you or someone you know has an autoimmune disease. These are conditions where your body's immune system mistakenly attacks its own healthy tissues. This study is about a new possible treatment, called ALLO-329, for some of these diseases, specifically systemic lupus erythematosus (lupus), idiopathic inflammatory myopathy (a muscle condition), and systemic sclerosis (scleroderma).
Doctors are always looking for better ways to help people with these long-term conditions. ALLO-329 is a type of 'CAR T-cell therapy'. This means it involves specially modified immune cells that are designed to target and fight certain cells that are causing problems in autoimmune diseases. Because this is a very new approach, this is a 'first-in-human' study, meaning it's the first time ALLO-329 is being tested in people. This phase of research is crucial for understanding how the treatment works.
The main aim of the study is to check if ALLO-329 is safe and how well your body can handle it. Researchers will also be looking for early clues about whether the treatment can help improve the symptoms and impact of your disease. This information will be used to plan future, larger studies to confirm if ALLO-329 can be an effective new treatment option.
Key takeaways
- This study tests a new treatment (ALLO-329) for severe autoimmune diseases.
- It's the first time this treatment is being used in people.
- The main goals are to check for safety and early signs of effectiveness.
- Participants must have active disease despite previous standard treatments.
- Careful monitoring and regular clinic visits are required.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 69 years old. You should have been diagnosed with one of the specific autoimmune diseases the study is looking at: lupus (even if it affects your kidneys), idiopathic inflammatory myopathy, or systemic sclerosis. Your disease must still be active, even though you have already tried standard treatments, including at least one immunosuppressive medication for at least three months (not just hydroxychloroquine).
It's also important that your body's main systems – like your blood, liver, heart, and lungs – are working well enough. If you are a woman who could get pregnant, you would need to have a negative pregnancy test and agree to use effective birth control for at least 12 months after the treatment. Men must agree to use birth control for at least 6 months. You must also be able and willing to attend all scheduled appointments and follow the study plan.
You would not be able to join if you have certain other serious health issues, such as active infections needing treatment, certain types of cancer within the last five years, or severe heart, liver, or lung problems that are not related to your autoimmune disease. Also, if you've previously had similar cell-based therapies or treatments targeting specific immune cells (CD19 or CD70), you wouldn't be eligible for this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 69 years old?
- Do you have active lupus, idiopathic inflammatory myopathy, or scleroderma?
- Has your disease remained active even after trying other regular treatments?
- Are your major organs (heart, lungs, liver, blood) generally healthy?
- Are you able and willing to attend all study appointments and follow instructions?
- Have you *not* had specific cell-based therapies or certain cancers recently?
What does participation involve?
If you decide to take part, you'll first have screening tests to make sure you're a good fit for the study. Once you're accepted, you'll receive a medication called cyclophosphamide, which is used to prepare your body for the main treatment. Then, you'll receive the ALLO-329 treatment as an infusion, likely into a vein.
After the treatment, you'll have regular visits to the clinic. These visits will involve various checks, like physical exams, blood tests, and possibly other scans or tests to monitor your health and see how the treatment is affecting your condition. These follow-up visits will continue for a certain period, and the study team will let you know the exact schedule. The total duration of your participation, including all follow-up, will be explained in detail before you decide to join.
Potential risks and benefits
Locations (13)
- Mayo ClinicVerified postcodePhoenix, United States· Recruiting
- University of Colorado DenverVerified postcodeAurora, United States· Recruiting
- Mayo ClinicVerified postcodeJacksonville, United States· Recruiting
- The University of Chicago Medical CenterVerified postcodeChicago, United States· Recruiting
- University of IowaVerified postcodeIowa City, United States· Recruiting
- Norton Cancer Institute, St. Matthews CampusVerified postcodeLouisville, United States· Recruiting
- Astera Cancer CareVerified postcodeEast Brunswick, United States· Recruiting
- Icahn School of Medicine at Mount SinaiVerified postcodeNew York, United States· Recruiting
- Duke University Medical CenterVerified postcodeDurham, United States· Recruiting
- Medical University of South CarolinaVerified postcodeCharleston, United States· Recruiting
- Prisma HealthVerified postcodeGreenville, United States· Recruiting
- LDS Hospital - lntermountain HealthVerified postcodeSalt Lake City, United States· Recruiting
Common questions
What is an 'allogeneic' CAR T-cell therapy?
Allogeneic means the treatment cells come from a healthy donor, not your own body. This is different from some other CAR T-cell therapies where your own cells are used.
What is the purpose of cyclophosphamide?
Cyclophosphamide is given before ALLO-329 to prepare your immune system and make sure the new treatment cells can work effectively in your body.
Will I know if I'm getting the real drug or a placebo?
This is a 'single-arm, open-label' study. This means everyone in the study will receive the active treatment (ALLO-329), and both you and your doctors will know you are receiving it.
What if my disease gets worse during the study?
Your health will be closely monitored by the study team. If your condition worsens or if you experience severe side effects, they will provide appropriate medical care and discuss your options.
Are there any costs for me to participate?
Typically, clinical trials cover the costs of the study-related treatment and visits. You should ask the study team for details about any potential costs or reimbursements for travel.
How to find out more
Allogene Therapeutics, Inc.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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