RecruitingEarly Phase 1NCT06613490

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

An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

24 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A single-center, open-label dose-escalation design to evaluate the safety and efficacy of 3 infusions of anti CD19 CAR NK cells (KN5501), as well as the expansion and persistence of KN5501 in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA); To evaluate the ability of KN5501 to clear CD19-positive B cells in patients to determine the feasibility of KN5501 for the treatment of refractory ASyS and or RA.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new type of cell therapy called CD19 CAR NK cells for people with two hard-to-treat autoimmune diseases: antisynthetase antibody syndrome (a condition involving muscle inflammation and lung disease) and rheumatoid arthritis that hasn't responded to prior treatments. CAR NK therapy reprograms immune cells to target the cells driving the autoimmune attack. **You may be eligible if...** - You have been diagnosed with antisynthetase antibody syndrome or rheumatoid arthritis based on established criteria - Your condition has not responded adequately to standard treatments - You are an adult willing to follow the full study protocol **You may NOT be eligible if...** - You have active, serious infections (including HIV or hepatitis) - You have had certain cancers in the past - You are pregnant or breastfeeding - You have significant heart, kidney, or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALanti CD19 CAR NK cells

This study is a single-arm, open-label and single-center exploratory clinical study to evaluate the safety and effectiveness of anti CD19 CAR NK cells in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA). All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by Anti-CD19 CAR NK cells infusion.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06613490


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