Search / Trial NCT06613490

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

Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

Description

No description provided

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.

About The First Affiliated Hospital With Nanjing Medical University

The First Affiliated Hospital of Nanjing Medical University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital is committed to implementing rigorous scientific methodologies to evaluate new therapies and treatment approaches. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital fosters a collaborative environment aimed at enhancing patient outcomes and contributing to the global medical community. Its strategic focus on translational medicine ensures that groundbreaking discoveries are efficiently translated into practical applications for patient care.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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