Clinical Trial

Disease: Systemic Lupus Erythematosus, SLE, (NCT06308978)

Disease info:

Systemic lupus erythematosus (SLE) is the most common form of lupus, a chronic autoimmune disease whereby the immune system attacks the body's own tissue and organs. SLE causes inflammation in connective tissues, such as cartilage and the lining of blood vessels. SLE can be mild or severe and can affect many parts of the body, including joints, skin, kidneys, heart, lungs, blood vessels, and brain. Individuals with SLE often experience periods of disease symptom flares and symptom remission. The symptoms of SLE vary within individuals and can range from mild to severe. 

Variants in multiple genes have been implicated in increasing the risk of developing SLE. The majority of these genes are involved in immune system function.

The first symptoms of SLE often manifest as fatigue, malaise, loss of appetite and weight loss. A characteristic symptom of SLE is the appearance of a red rash across the nose and cheeks, referred to as a “butterfly rash”. Skin problems are common in SLE, including a sun-reactive skin rash, calcium deposits under the skin known as calcinosis, damaged blood vessels and small red spots called petechiae. Kidney disease is also associated with SLE, as well as heart problems and symptoms arising from nervous system damage such as seizures. 
Other symptoms of lupus include arthritis, an unexplained fever, chest pain especially when inhaling or lying down, hair loss, discoloured fingers or toes, sun sensitivity, swelling in legs and around eyes, mouth ulcers and swollen glands, headaches, and dizziness.

There is currently no cure for lupus. Treatment involves managing symptom flares and reducing organ damage.

Overall prevalence is estimated to be 1-5 in 10,000. SLE affects women approximately nine times more often than men.
Official title:
A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus


Name: Fate Trial Disclosure

Phone: 866-875-1800



United States, Minnesota
University of Minnesota Medical School, Minneapolis, Minnesota, United States, 55455

Unites States, Nebraska
University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Study start:
Feb. 24, 2024
32 participants
Gene editing method:
Type of edit:
Gene knock-out, gene knock-in
Anti-CD19 molecule, T Cell Receptor Alpha Constant (TRAC)
Delivery method:
Electroporation and adeno-associated virus (AAV) - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

Last updated: May. 12, 2024
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