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NOT YET RECRUITING
NCT07746453
NA

Universal STAR-T Cell Injection in Autoimmune Kidney Diseases

Sponsor: Guangdong Provincial People's Hospital

View on ClinicalTrials.gov

Summary

This is an investigator initiated, single-arm, open-label, dose-escalation study to explore the preliminary efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection which is a CD19 and BCMA bispecific CAR-T cells in patients with autoimmune kidney diseases. Approximately 10-24 adult participants diagnosed as IgA nephropathy and primary membranous nephropathy will be enrolled. Three dose levels (1.5 E6 STAR-T cells/kg, 3.0 E6 STAR-T cells/kg and 4.5 E6 STAR-T cells/kg) will be established in this study, and the universal STAR-T cell will be administered as a single intravenous infusion. A recommended dose will be selected for subsequent dose-expansion studies to evaluate the safety and efficacy of universal STAR-T cell injection in participants with autoimmune kidney diseases based on the safety, PK results, and preliminary efficacy data. This study includes the screening period (D-28 to D-6), pre-clearance treatment and observation period (D-5 to D-1), cell infusion and main study endpoint observation period (D0 to W12 after infusion), and extended follow-up period (W12 to W104).

Official title: An Exploratory Study to Evaluate the Safety and Efficacy of Universal STAR-T Cell Injection in Subjects With Autoimmune Kidney Diseases

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-08-31

Completion Date

2029-10-01

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

Universal STAR-T Cell

There are three dose levels of STAR-T cells injection(1.5 E6 STAR-T cells/kg, 3.0 E6 STAR-T cells/kg and 4.5 E6 STAR-T cells/kg) .

Locations (1)

Guangdong Provincial People's Hospital.

Guangdong, Guangzhou, China