NCT07095075

A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases

An Open-label Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases (r/r AID)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Nanjing Legend Biotech Co. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-DKS1 in adult subjects with relapsed/refractory autoimmune diseases.

Detailed description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-DKS1, a chimeric antigen receptor (CAR) -NK cell therapy in subjects with relapsed/refractory autoimmune diseases. Patients who meet the eligibility criteria will receive LUCAR-DKS1 infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment LUCAR-DKS1 infusion) and follow-up.

Conditions

• Relapsed/Refractory Autoimmune Diseases

Interventions

Type	Name	Description
BIOLOGICAL	LUCAR-DKS1 NK cells	Prior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Timeline

• Start date: 2025-10-14
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-07-31
• Last updated: 2025-12-10

Locations

5 sites across 1 country: China