Actively Recruiting
An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injections 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
52 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
Researchers are evaluating the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed or refractory B-cell related autoimmune diseases. This early phase 1 pilot study plans to enroll 15 patients to assess the treatment's safety, feasibility, and effectiveness. The study also explores how well KN5501 expands, persists, and depletes CD19 positive B cells in these patients. Participants will receive a preparatory treatment with Fludarabine and Cyclophosphamide on three days before the infusion of anti-CD19 CAR NK cells. The trial includes two dose levels (6x10^9 and 9x10^9 cells) for dose escalation. This is a single-arm, open-label study without a placebo group. During the study, researchers will monitor participants closely for dose limiting toxicities and adverse events within the first 4 weeks and at 12, 24, 36, and 52 weeks after infusion. Effectiveness will be evaluated by disease control and remission rates at the same time points. Participants will undergo regular assessments including clinical evaluations and laboratory tests, with follow-up lasting up to one year after treatment.
CONDITIONS
Brief 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...
- Subjects voluntarily agree to participate and sign informed consent
- Diagnosed with relapsed/refractory B-cell related autoimmune diseases with moderately to severely active disease
- Age between 18 and 70 years, any gender
- Estimated survival longer than 12 weeks
- Adequate organ function including serum creatinine clearance per age/sex, AST and ALT levels less than or equal to 3 times the upper limit of normal
- ECOG performance status of 2 or less
- Left ventricular ejection fraction of 45% or higher
- Prior treatment with oral corticosteroids plus an 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 allergic reactions
- Presence of genetic syndromes such as Fanconi syndrome, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes
- Active or uncontrolled infections requiring intravenous antimicrobials or severe viral, bacterial, or systemic fungal infections
- Grade III or IV heart failure (NYHA classification)
- History of epilepsy or other central nervous system diseases
- History of other primary malignant tumors except cured non-melanoma skin cancer or primary cervical cancer, or inactive tumors
- Significant bleeding disorders including gastrointestinal bleeding, coagulation disorders, or hypersplenism
- Use of systemic corticosteroids within 2 weeks prior to treatment
- Unstable angina, symptomatic congestive heart failure, or recent myocardial infarction within 6 months
- Females who are pregnant, breastfeeding, or planning pregnancy within six months
- Participation in another clinical trial within the past 3 months
- Any condition that increases risk or interferes with trial outcomes as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive preparatory chemotherapy with Fludarabine and Cyclophosphamide before receiving the CAR NK cell infusion.
1 visit for chemotherapy administration
Duration - Single infusion day
Participants receive an infusion of anti-CD19 CAR NK cells as the main treatment intervention.
1 infusion visit (in-person)
Duration - Up to 52 weeks after infusion
Participants are monitored for safety and efficacy after treatment including assessments of adverse events and disease control.
Visits at 4, 12, 24, 36, and 52 weeks after infusion
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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