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

Recruiting now · Early Phase 1

Conditions studied: Autoimmune Diseases

In brief

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\^9 cells, 9×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases.

Key facts

Study ID

NCT06318533

Run by

YANRU WANG

People needed

15

Starts

2024-03-13

Expected to finish

2027-03-13

Last updated by the study team

2025-05-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
• Age: ≥ 18 years old and ≤ 70 years old, male or female
• Subjects with estimated survival > 12 weeks
• 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)
• ECOG performance ≤ 2
• Left ventricular ejection fraction (LVEF) ≥ 45%
• Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment

You may not qualify if…

• 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
• Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes
• Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections
• Subjects with grade III or IV heart failure (NYHA classification)
• History of epilepsy or other central nervous system (CNS) diseases
• History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors
• Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism
• Subjects were treated with systemic corticosteroids concomitantly within 2 weeks prior to treatment
• Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months
• Females who are pregnant, lactating, or planning a pregnancy within six months
• Subjects who have received other clinical trial treatment within 3 months
• Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome

Where it is running

• Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (enrolling)
• Jiangsu University Affiliated Hospital — Zhenjiang, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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