An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option using special immune cells called CD19 CAR NK cells for patients who have refractory antisynthetase antibody syndrome (ASyS) or rheumatoid arthritis (RA). The goal is to see if three infusions of these cells can help improve symptoms and reduce the number of certain harmful cells in the body. The study will focus on how safe this treatment is and whether it can effectively help patients who haven't responded well to other treatments.

To participate in this study, you need to be an adult between the ages of 18 and 70 who has been diagnosed with RA or ASyS for at least three months and has had a poor response to at least one previous treatment. Participants will undergo several assessments to ensure they are healthy enough for the trial. If you decide to join, you can expect to receive the infusions and be monitored closely for any side effects or improvements in your condition. It’s important to know that this trial is not yet recruiting participants, so there will be a wait before it starts.

Gender

ALL

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.