Clinical Trial

Disease: Relapsed or Refractory Autoimmune Diseases, (NCT05859997)

Disease info:

This trial is for relapsed or refractory autoimmune diseases including systemic lupus erythematosus (SLE), Sj√∂gren's Syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated systemic vasculitis, and antiphospholipid syndrome.

Autoimmune diseases occur when an individuals immune system incorrectly attacks the healthy cells of organs and tissues. There are over 80 types of different autoimmune diseases affecting various parts of the body, including the hair, liver, pancreas, and more. Symptoms vary and depend on the part of your body that's affected. Common symptoms include redness, swelling, heat, and pain due to chronic inflammation. The symptoms of autoimmune diseases fluctuate between flare-ups, where symptoms are exacerbated, and remission, where symptoms alleviate, for a period of time.

The exact causes of autoimmune diseases can be complex and poorly defined. Autoimmune diseases tend to be familial, suggesting genetics may play a role in  predisposition. Viruses, certain chemicals, and other environmental factors may trigger an autoimmune disease.

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.

Source: Autoimmune Diseases - MedlinePlus

Frequency:
Millions of Americans of all ages have autoimmune diseases. Women develop many types of autoimmune diseases much more often than men.
Official title:
A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (BRL-301) in the Treatment of Relapse or Refractory Autoimmune Diseases
Who:

Contact

Name: Huji Xu, Doctor

Phone: 86021-81885514

Email: xuhuji@smmu.edu.cn

 

Partners:

Shanghai Changzheng Hospital

Locations:

China, Shanghai
Shanghai ChangZheng hospital, Shanghai, Shanghai, China, 200433

Study start:
May. 17, 2023
Enrollment:
15 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-in, gene knock-out
Gene:
Anto-CD19 Chimeric Antigen Receptor (CAR) GHVD genes knock-out Immune rejection genes knock-out
Delivery method:
Electroporation - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.

The study had the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Follow-up.

Last updated: Mar. 28, 2024
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