A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases
Study Title: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases
Includes Participants with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
Sponsor Name: Fate Therapeutics
Purpose of Study: The purpose of this study is to establish the safety and potential effectiveness of investigational FT819 in participants with moderate to severe systemic lupus erythematosus (SLE) with or without lupus nephritis (lupus-related kidney disease, LN).
FT819 is an enhanced CAR T-cell therapy that is available on-demand when a patient needs it. T-cell therapies work by recognizing and eliminating certain cells in the body that are associated with lupus disease activity.
What Does this Study Involve?
- Qualification: You will undergo screening procedures to determine eligibility, which involve assessments of disease activity and lab tests.
- No extra procedures required. FT819 is pre-made, and ready for immediate infusion. This study does not require leukapheresis (separation of T cells from your blood) and a waiting period (for genetic preparation of CAR T cells in the lab)
- Pre-treatment. Depending on the treatment plan, you may receive a less intense form of chemotherapy prior to receiving FT819 to reduce the number of white blood cells that could obstruct the activity of FT819 therapy. In some cases, you may not receive any chemotherapy.
- Treatment Period: Treatment with FT819 is a single infusion. You may have the option for a second infusion later, if you and your study doctor think you may benefit from it. After treatment with FT819, you may remain in the hospital for 3 days for monitoring.
- Short-term Follow-up Period: After release from the hospital, you will continue to be monitored for up to 2 years to assess your disease.
- Long-term Follow-up Period: The short-term assessment transitions to the long-term follow-up period lasting for up to 15 years. In this period monitoring will occur once a year which can be done in person, by telephone, through medical records, or by email/mail. No clinical or laboratory information will be collected during this time.
You or Your Child May Qualify for This Study If You:
- Are between 12 and 70 years old.
- Have a diagnosis of SLE with or without LN.
- Have moderate to severe disease where at least three prior treatments were ineffective.
- Do not have active/recent cancer, prior CAR T-cell therapy, or organ transplant.
There are additional eligibility requirements which the study team will discuss with you. If you don’t qualify now, you may choose to be contacted later to see if you qualify in the future.
Study Type:
- Interventional
- Phase 1 multicenter
- Currently a US study and will be expanding internationally in 2025
Eligible patients may receive support to help with any or all following items:
- Travel assistance for flights, car services, mileage reimbursement and/or compensation on study visit days
- Accommodations and meals for both participant and companion
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.