A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases

Launched by YANRU WANG · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option using a special type of immune cell called CD19 CAR NK cells (KN5501) for patients with certain autoimmune diseases that have not responded well to previous treatments. The study aims to find out how safe and effective this therapy is for adults aged 18 to 70 with active B-cell related autoimmune diseases. Participants who join the trial will receive KN5501 and will be monitored for safety and how well the treatment works.

To be eligible for this study, participants must be willing to follow all the study procedures and have had their disease not fully respond to standard treatments. They should also have a life expectancy of more than 12 weeks and meet certain health criteria, like having good kidney and liver function. However, this trial is not for everyone; for example, individuals with severe allergies, active infections, or certain heart and neurological conditions cannot participate. Those who join can expect regular check-ups and assessments to track their health and the therapy's effects. This trial provides a chance to explore a new treatment that could help individuals struggling with difficult-to-treat autoimmune diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures
• • 2. Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
• • 3. Age: ≥ 18 years old and ≤ 70 years old, male or female
• • 4. Subjects with estimated survival \> 12 weeks
• • 5. Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)
• • 6. ECOG performance ≤ 2
• • 7. Left ventricular ejection fraction (LVEF) ≥ 45%
• • 8. Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment
• 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. History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors
• • 7. Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism
• • 8. Subjects were treated with systemic corticosteroids concomitantly within 2 weeks prior to treatment
• • 9. Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months
• • 10. Females who are pregnant, lactating, or planning a pregnancy within six months
• • 11. Subjects who have received other clinical trial treatment within 3 months
• • 12. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome