Preliminary Clinical Study of UTAA09 Injection in the Treatment of

Status Not yet recruiting

Clinical Trial Summary

To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). 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, 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 subject's voluntary withdrawal, whichever occurred first. All adverse events were recorded from the beginning of the subject's elutriation pre-treatment (if it occurred) until 3 months after the subject received cell transfusion or disease progression/recurrence 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 progression/recurrence 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06417398
Study type	Interventional
Source	PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Contact	jian wu, Doctor
Phone	15358805676
Email	njwujian@163.com
Status	Not yet recruiting
Phase	Early Phase 1
Start date	May 14, 2024
Completion date	May 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04226131` - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics	N/A
Completed	`NCT04171414` - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis	Phase 3
Completed	`NCT02833350` - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)	Phase 2
Completed	`NCT04255134` - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)	Phase 4
Recruiting	`NCT05615246` - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed	`NCT03248518` - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases	N/A
Completed	`NCT03514355` - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms	N/A
Recruiting	`NCT06005220` - SBD121, a Synbiotic Medical Food for RA Management	N/A
Recruiting	`NCT05451615` - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis	Phase 3
Completed	`NCT05054920` - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis	N/A
Completed	`NCT02037737` - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting	N/A
Recruiting	`NCT04079374` - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel	Phase 3
Completed	`NCT02504268` - Effects of Abatacept in Patients With Early Rheumatoid Arthritis	Phase 3
Recruiting	`NCT05496855` - Remote Care in People With Rheumatoid Arthritis	N/A
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting	`NCT06031415` - Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus	Phase 1
Recruiting	`NCT06103773` - A Study of Single and Multiple Oral Doses of TollB-001	Phase 1
Completed	`NCT05999266` - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting	`NCT05302934` - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting	`NCT04169100` - Novel Form of Acquired Long QT Syndrome	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms