Actively Recruiting
A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
Led by YANRU WANG · Updated on 2025-05-11
15
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Y
YANRU WANG
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\^9 cells, 9×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases.
CONDITIONS
Official Title
A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Have relapsed or refractory autoimmune disease with moderate to severe activity
- Age between 18 and 70 years, any gender
- Estimated survival greater than 12 weeks
- Adequate organ function, including kidney and liver tests within normal limits or less than 3 times upper limit
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Left ventricular ejection fraction (LVEF) of 45% or higher
- Treated with oral corticosteroids plus immunosuppressive or biologic agent for at least 2 weeks before enrollment
You will not qualify if you...
- Known severe allergic reactions or hypersensitivity to cyclophosphamide, fludarabine, tozumabs, or history of severe allergy
- Presence of genetic syndromes like Fanconi, Kostmann, Shwachman, or other bone marrow failure syndromes
- Active or uncontrolled infections needing intravenous antibiotics or severe viral, bacterial, or fungal infections
- Severe heart failure classified as NYHA grade III or IV
- History of epilepsy or other central nervous system diseases
- History of primary malignant tumors except cured non-melanoma skin cancer or cervical cancer, or inactive tumors
- Significant bleeding disorders such as gastrointestinal bleeding, coagulation issues, or hypersplenism
- Use of systemic corticosteroids within 2 weeks before treatment
- Recent unstable angina, symptomatic heart failure, or heart attack within 6 months
- Pregnancy, breastfeeding, or planning pregnancy within 6 months
- Participation in other clinical trials within the last 3 months
- Any condition judged by investigators to increase risk or interfere with trial results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 212001
Actively Recruiting
2
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China, 212001
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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