An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
- Registration Number
- NCT06464679
- Lead Sponsor
- Changhai Hospital
- Brief Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety and feasibility of CD19 CAR-NK cells for the treatment of patients with autoimmune diseases. The secondary objective is to evaluate the efficacy of CD19 CAR-NK cells in patients with autoimmune diseases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CD19 CAR NK cells anti-CD19 CAR NK cells -
- Primary Outcome Measures
Name Time Method Incidence of Dose-Limiting Toxicity (DLT) up to 48 weeks after infusion To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases
Incidence of Treatment Emergent Adverse Events (TEAEs) up to 48 weeks after infusion To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases
- Secondary Outcome Measures
Name Time Method The overall response rate (ORR) Time Frame: 1, 3, 6, 12 and 12 months after infusion To characterize the efficacy of CD19 CAR NK Cell (KN5501) for Relapsed/Refractory autoimmune diseases
Disease control rate (DCR) Time Frame: 1, 3, 6, 12 and 12 months after infusion To characterize the efficacy of CD19 CAR NK Cell (KN5501) for Relapsed/Refractory autoimmune diseases
Trial Locations
- Locations (1)
Changhai Hospital
🇨🇳Shanghai, China