Clinical Trial

Disease: Systemic Lupus Erythematosus, SLE, (NCT06255028)

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:
The CALiPSO-1 Study: A Study of CNTY-101, a CD19-targeted CAR iNK Cell Product, in Participants With Moderate to Severe Systemic Lupus Erythematosus


Name: Nikolaus Trede

Phone: 8885067670


Study start:
Aug. 1, 2024
26 participants
Gene editing method:
Type of edit:
6 edits, 2 knockouts and 4 knock-ins.
Knockout of beta-2 microglobulin (b2M) and MHC Class II Transactivator (CIITA) Knock-in of HLA-E, CD19 CAR with FMC63 binder, a truncated Epidermal Growth Factor Receptor (EGFR) containing Cetuximab binding epitope and IL-15.
Delivery method:
- Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting


CALiPSO-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety and efficacy of CNTY-101 in participants with moderate to severe systemic lupus erythematosus.

Last updated: Apr. 20, 2024
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