drugset / Trial / NCT06361745

Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

NCT06361745

NaSingle-groupOpen-labelTreatment

Summary

Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). Secondary purpose: To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID. To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID. To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects. To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects.

Timeline

Start
2024-04-02
Primary completion
2024-12-01
Completion
2025-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject UTAA09 Cell therapy 1e+08 cells Intravenous
Subject UTAA09 Cell therapy 1e+09 cells Intravenous