Using CD19 CAR NK cells to treat refractory antisynthetase antibody syndrome and rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and efficacy of three infusions of anti CD19 CAR NK cells (KN5501) in patients with refractory antisynthetase antibody syndrome and rheumatoid arthritis. It employs a single-center, open-label, dose-escalation design to assess the treatment's ability to clear CD19-positive B cells and its overall impact on disease symptoms. The study aims to determine the expansion and persistence of KN5501 in the patient population over the course of treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wenfeng Tan, PhD, MD
• Email: tanwenfeng@jsph.org.cn
• Phone: 086 18061202878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.