An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Overview
- Phase
- Phase 1
- Intervention
- anti-CD19 CAR NK cells
- Conditions
- Autoimmune Diseases
- Sponsor
- Changhai Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Incidence of Dose-Limiting Toxicity (DLT)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CD19 CAR NK cells
Intervention: anti-CD19 CAR NK cells
Outcomes
Primary Outcomes
Incidence of Dose-Limiting Toxicity (DLT)
Time Frame: 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)
Time Frame: up to 48 weeks after infusion
To characterize the safety of CD19 CAR NK Cells (KN5501) for Relapsed/Refractory autoimmune diseases
Secondary Outcomes
- The overall response rate (ORR)(Time Frame: 1, 3, 6, 12 and 12 months after infusion)
- Disease control rate (DCR)(Time Frame: 1, 3, 6, 12 and 12 months after infusion)