ClinicalTrials.gov record NCT06613490
An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
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
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This early phase 1, single‑center, open‑label dose‑escalation study gives adults with refractory antisynthetase syndrome or rheumatoid arthritis lymphodepleting chemotherapy followed by three infusions of anti‑CD19 CAR NK cells (KN5501). The study mainly monitors safety (dose‑limiting toxicities and adverse events) and also looks for signs of treatment effect and how long the infused cells persist. Participants are followed and monitored for adverse events and responses for up to about 52 weeks after infusion.
What it is studying. The study tests the safety and tolerability of anti‑CD19 CAR NK cells (KN5501) in people with refractory antisynthetase syndrome or rheumatoid arthritis. It also measures whether KN5501 can clear CD19‑positive B cells, how well the infused cells expand and persist in the body, and collects early evidence of treatment activity.
What the researchers hope to learn. To characterize safety by recording dose‑limiting toxicities and treatment‑emergent adverse events; to evaluate efficacy measures such as overall response rate; to assess KN5501 expansion, persistence, and ability to clear CD19‑positive B cells; and to determine the feasibility of using KN5501 for refractory antisynthetase syndrome and/or rheumatoid arthritis.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- anti CD19 CAR NK cells
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Subjects voluntarily sign the Informed Consent Form (ICF) , participate in this clinical study and be willing to follow and be able to complete all trial procedures.
- Defined according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, adult patients with RA diagnosed ≥3 months prior to screening;Moderately to severely active RA;Poor response, or loss of response, or intolerance to at least one conventional synthetic DMARD (csDMARD) or biologic DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
- Defined according to the 2020 ENMC-DM classification diagnostic criteria. Adult patients with ASyS diagnosed ≥3 months prior to screening; patients with moderately severe active ASyS.
- Age: ≥ 18 years old and ≤ 70 years old, male or female.
- Subjects with estimated survival > 12 weeks.
- Serum creatinine clearance meets the relevant age/sex criteria, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN).
- ECOG score 0 - 2.
- The heart structure is essentially normal by echocardiography and Left ventricular ejection fraction (LVEF) ≥45%.
- 2 weeks after the subject received the last dose treatment (hormonal, immunosuppressive or other experimental treatment).
Exclusion criteria
- Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions.
- Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes.
- Subjects with Active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections.
- Subjects with grade III or IV heart failure (NYHA classification).
- History of epilepsy or other central nervous system (CNS) diseases.
- Subjects with history of malignancy except cured of carcinoma in situ of the skin or cervix, and patients with inactive tumors.
- Subjects with pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism.
- The subject with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months.
- Females who are pregnant, lactating, or planning a pregnancy within six months.
- Subjects who have received other clinical trial treatment within 3 months.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After screening tests (blood work and heart ultrasound) to confirm eligibility, participants receive lymphodepletion with fludarabine and cyclophosphamide followed by three infusions of anti‑CD19 CAR NK cells (KN5501). They will have close safety monitoring and clinic visits after infusion, with blood tests and clinical assessments; safety is followed up to 52 weeks and response assessments are recorded at multiple time points (registry lists follow‑up up to 52 months). Participants must have completed required treatment washouts before enrollment and cannot be pregnant or breastfeeding during the study.
How the study is structured. Interventional, single‑group, open‑label, dose‑escalation (early phase 1) study. All participants receive fludarabine/cyclophosphamide lymphodepletion followed by three infusions of anti‑CD19 CAR NK cells and are monitored over time for safety and response. There is no placebo or masking.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on anti-synthetase syndrome
Important dates
- Study start
- May 20, 2025 (estimated)
- Primary completion
- Oct 20, 2025 (estimated)
- Study completion
- Oct 20, 2026 (estimated)
- Target enrollment
- 24 participants (estimated)
- Last updated on registry
- Apr 30, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Principal investigator
- Wenfeng Tan, Clinical Professor
The First Affiliated Hospital with Nanjing Medical University - Collaborators
- Rui Therapeutics Co., Ltd
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Wenfeng Tan, PhD, MD 📞 086 18061202878 ✉ tanwenfeng@jsph.org.cn
- Hanxiao You, PhD, MD 📞 086 18800181269 ✉ youhanxiao@jsph.org.cn
Participating sites (1)
- The First Affiliated Hospital with Nanjing Medical UniversityRecruiting
Nanjing, Jiangsu, 210029 · China
- Wenfeng Tan, PhD, MD · 086 18061202878 · tanwenfeng@jsph.org.cn
- Hanxiao You, PhD, MD · 086 18800181269 · youhanxiao@jsph.org.cn
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- dose-escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- Informed Consent Form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- prior to screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- creatinine clearance
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- ECOG score
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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