Using CAR NK cells to treat autoimmune diseases

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 pilot study evaluates the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients suffering from relapsed or refractory B-cell related autoimmune diseases. It is a single-arm, open-label trial that plans to enroll 15 patients in a dose-escalation format, administering two different doses of the treatment. The primary goal is to assess the safety and feasibility of KN5501, while secondary objectives focus on its effectiveness and the ability to deplete CD19 positive B cells. The study also aims to explore the expansion and persistence of the CAR NK cells in the patients.

Why it matters

Who can join: the full rules

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 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
11. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome

Where it's running

• Affiliated Hospital of Jiangsu University
  Zhenjiang, Jiangsu, China Recruiting
• Jiangsu University Affiliated Hospital
  Zhenjiang, Jiangsu, China Recruiting

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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.