Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417398
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-27
Brief Title:
Preliminary Clinical Study of UTAA09 Injection in the Treatment of RelapsedRefractory Autoimmune Diseases
Sponsor:
PersonGen BioTherapeutics Suzhou Co Ltd
Organization:
PersonGen BioTherapeutics Suzhou Co Ltd
Study Overview
Official Title:
Preliminary Clinical Study of UTAA09 Injection in the Treatment of RelapsedRefractory Autoimmune Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety of UTAA09 injection in the treatment of relapsedrefractory RR autoimmune disease AID
To evaluate the pharmacokinetic PK profile of UTAA09 injection in patients with RR AID
To evaluate the pharmacodynamic PD characteristics of UTAA09 injection in patients with RR AID
To evaluate the initial efficacy of UTAA09 injection in the treatment of RR AID subjects
To evaluate the immunogenicity of UTAA09 injection in RR AID subjects
To evaluate the pharmacokinetic PK profile of UTAA09 injection in patients with RR AID
To evaluate the pharmacodynamic PD characteristics of UTAA09 injection in patients with RR AID
To evaluate the initial efficacy of UTAA09 injection in the treatment of RR AID subjects
To evaluate the immunogenicity of UTAA09 injection in RR AID subjects
Detailed 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 relapsedrefractory 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 therapeutic efficacy was evaluated at a frequency of 28d 2m 3m 4m 5m 6m 8m 10m 12m after cell transfusion and tumors were evaluated until disease progression PD new anti-disease therapy death intolerable toxicity investigator decision or subjects voluntary withdrawal whichever occurred first
All adverse events were recorded from the beginning of the subjects elutriation pre-treatment if it occurred until 3 months after the subject received cell transfusion or disease progressionrecurrence or initiation of a new anti-disease therapy or the end of the study whichever occurred first and 3 months after cell transfusion or disease progressionrecurrence or initiation of a new anti-disease therapy whichever occurred first until the end of the study Only adverse events associated with the study product were collected
All adverse events were recorded from the beginning of the subjects elutriation pre-treatment if it occurred until 3 months after the subject received cell transfusion or disease progressionrecurrence or initiation of a new anti-disease therapy or the end of the study whichever occurred first and 3 months after cell transfusion or disease progressionrecurrence or initiation of a new anti-disease therapy whichever occurred first until the end of the study Only adverse events associated with the study product were collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None