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Clinical Trial 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.


Clinical Trial Description

This clinical trial was designed as a single-arm, open-label, single-center, investigator-initiated early-stage clinical study to evaluate the safety of UTAA09 injection in patients with relapsed/refractory AID. After signing the informed consent letter, qualified subjects were screened for infusion of UTAA09 injection, and their blood was collected before and after infusion for pharmacokinetics, pharmacodynamics, immunogenicity, safety and other evaluation. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of 14d, 28d, 2m, 4m, 6m, 8m, 10m, 12m, 15m, 18m, 21m, 24m after cell transfusion until disease progression (PD), new anti-disease therapy, death, intolerable toxicity, investigator decision, or subject's voluntary withdrawal. Whichever comes first. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06361745
Study type Interventional
Source PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Contact songlou yin, master
Phone 0516-85806210
Email yinsonglou@163.com
Status Recruiting
Phase N/A
Start date April 2, 2024
Completion date March 1, 2025

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