NCT06613490 An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
| NCT ID | NCT06613490 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Antisynthetase Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2025-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-05-20 with a primary completion date of 2025-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. 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). 3. 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. 4. Age: ≥ 18 years old and ≤ 70 years old, male or female. 5. Subjects with estimated survival \> 12 weeks. 6. 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). 7. ECOG score 0 - 2. 8. The heart structure is essentially normal by echocardiography and Left ventricular ejection fraction (LVEF) ≥45%. 9. 2 weeks after the subject received the last dose treatment (hormonal, immunosuppressive or other experimental treatment). Exclusion Criteria: 1. 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. 2. Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes. 3. Subjects with Active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections. 4. Subjects with grade III or IV heart failure (NYHA classification). 5. History of epilepsy or other central nervous system (CNS) diseases. 6. Subjects with history of malignancy except cured of carcinoma in situ of the skin or cervix, and patients with inactive tumors. 7. Subjects with pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism. 8. The subject with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months. 9. Females who are pregnant, lactating, or planning a pregnancy within six months. 10. Subjects who have received other clinical trial treatment within 3 months.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06613490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Antisynthetase Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06613490 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06613490 currently recruiting?
Yes, NCT06613490 is actively recruiting participants. Contact the research team at tanwenfeng@jsph.org.cn for enrollment information.
Where is the NCT06613490 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06613490 clinical trial?
NCT06613490 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 24 participants.