SEEKAnti-CD19/BCMA CAR-NK Cells for B Cell Mediated Autoimmune Disease
anti-CD19/BCMA CAR NK cells (KN5601)
Urogenital Diseases+10
+ Autoimmune Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: January 30, 2025
Actual date on which the first participant was enrolled.This study focuses on evaluating a new treatment using CAR-NK cells for people with certain autoimmune diseases, specifically systemic lupus erythematosus (SLE) and multi-drug resistant nephrotic syndrome (MDR-SRNS). These conditions occur when the immune system mistakenly attacks healthy tissues, leading to serious health problems, including organ damage. Current treatments are not effective for everyone, especially children with SLE who often experience more severe symptoms. There's a significant need for new treatments, as many patients struggle to achieve remission. CAR-NK cell therapy, a method that uses modified immune cells to target disease-related cells, may offer a safer, more affordable, and effective alternative to existing therapies. Participants in this study will receive CAR-NK cells, which are specially engineered immune cells designed to target and destroy harmful cells in the body, through an injection. The study aims to assess the safety and effectiveness of this treatment approach. Researchers will closely monitor participants for any changes in their condition and check for potential side effects. This early phase study hopes to provide insight into whether CAR-NK cell therapy can be a viable treatment option for these challenging autoimmune diseases, potentially improving outcomes for patients who have not responded well to other treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 3 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000
Hangzhou, ChinaOpen Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000 in Google Maps