Actively Recruiting
An Exploratory Clinical Study of CD19 CAR 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
74 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
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of 3 infusions of anti CD19 CAR NK cells (KN5501), as well as the expansion and persistence of KN5501 in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA); To evaluate the ability of KN5501 to clear CD19-positive B cells in patients to determine the feasibility of KN5501 for the treatment of refractory ASyS and or RA.
CONDITIONS
Official 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...
- Adults aged 18 to 70 years
- Willing to sign informed consent and complete all trial procedures
- Diagnosed with rheumatoid arthritis at least 3 months before screening, meeting 2010 ACR/EULAR criteria, with moderate to severe active disease
- Poor response, loss of response, or intolerance to at least one synthetic, biologic, or targeted DMARD
- Diagnosed with antisynthetase antibody syndrome at least 3 months before screening, meeting 2020 ENMC-DM criteria, with moderately severe active disease
- Estimated survival longer than 12 weeks
- Kidney function and liver enzymes within acceptable limits (creatinine clearance per age/sex criteria; AST and ALT ≤ 3 times upper limit of normal)
- ECOG performance status 0 to 2
- Normal heart structure by echocardiography and left ventricular ejection fraction ≥ 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 history of severe allergic reactions
- Diagnosis of Fanconi syndrome, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes
- Active or uncontrolled infections requiring parenteral antimicrobials or severe viral, bacterial, or systemic fungal infections
- Grade III or IV heart failure according to NYHA classification
- History of epilepsy or other central nervous system diseases
- History of malignancy except cured carcinoma in situ of 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 past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
H
Hanxiao You, PhD, MD
CONTACT
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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