Actively Recruiting
An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-04-30
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
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 refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA). This early phase 1 study aims to determine if KN5501 can clear CD19-positive B cells and assess its expansion and persistence in these patients, who have not responded well to other treatments. Participants will receive three infusions of anti CD19 CAR NK cells following lymphodepletion with fludarabine and cyclophosphamide. The study uses a dose-escalation design conducted at a single center in an open-label format. All subjects will undergo the same treatment regimen and be closely monitored throughout the trial. During the study, participants will be evaluated for treatment safety, including dose-limiting toxicities and adverse events for up to 52 weeks after infusion. Researchers will also measure overall response rates at multiple time points up to 52 months post-infusion. Assessments will include heart function tests, laboratory tests for liver and kidney function, and physical evaluations, with a total follow-up extending over several years to track treatment effects and safety.
CONDITIONS
Brief Title
An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and able to complete all trial procedures
- Adults aged 18 to 70 years, male or female
- Diagnosed with rheumatoid arthritis for at least 3 months with moderate to severe activity
- Diagnosed with antisynthetase antibody syndrome for at least 3 months with moderately severe activity
- Poor response, loss of response, or intolerance to at least one conventional synthetic DMARD, biologic DMARD, or targeted synthetic DMARD
- Estimated survival greater than 12 weeks
- Serum creatinine clearance meets age/sex criteria; AST and ALT less than or equal to 3 times the upper limit of normal
- ECOG performance status score between 0 and 2
- Normal heart structure by echocardiography and left ventricular ejection fraction at least 45%
- At least 2 weeks since last dose of hormonal, immunosuppressive, or experimental treatment
You will not qualify if you...
- Known severe allergic reactions or hypersensitivity to cyclophosphamide, fludarabine, tozumabs, or other medications used in the trial
- Diagnosis of genetic syndromes such as Fanconi syndrome, Kostmann syndrome, Shwachman syndrome, or bone marrow failure syndromes
- Active or uncontrolled infections requiring intravenous antimicrobials or severe viral, bacterial, or fungal infections
- Grade III or IV heart failure (NYHA classification)
- History of epilepsy or other central nervous system diseases
- History of malignancy except cured carcinoma in situ of the skin or cervix, or inactive tumors
- Pronounced bleeding disorders such as gastrointestinal bleeding, coagulation disorders, or hypersplenism
- Unstable angina, symptomatic congestive heart failure, or myocardial infarction within the last 6 months
- Females who are pregnant, breastfeeding, or planning pregnancy within six months
- Participation in another clinical trial within the last 3 months
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 - Up to 52 weeks after infusion
Participants receive fludarabine/cyclophosphamide lymphodepletion followed by infusion of anti CD19 CAR NK cells to treat refractory antisynthetase antibody syndrome and rheumatoid arthritis.
Multiple visits during lymphodepletion and infusion period, followed by regular visits for monitoring
Duration - Up to 52 weeks after infusion
Participants are monitored for safety and treatment response, including adverse events and overall response rate assessments.
Visits at 4, 12, 24, 36, and 52 weeks after infusion
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
W
Wenfeng Tan, PhD, MD
H
Hanxiao You, PhD, MD
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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