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

Not Applicable

Recruiting

• Conditions: Systemic Lupus Erythematosus; IgG4 Related Disease; Systemic Sclerosis; Primary Sjögren Syndrome; Idiopathic Inflammatory Myopathies
• Interventions: Biological: T cell injection targeting CD19 chimeric antigen receptor

• Registration Number: NCT06361745
• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Brief 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.

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 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 Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-02
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T cell injection targeting CD19 chimeric antigen receptor	T cell injection targeting CD19 chimeric antigen receptor	Intravenous administration, 1 bag each time (depending on individual differences), dose: 1×108-1×109 CD19-CAR-gdT (UTAA09 injection), the investigator can decide whether to reduce or increase the dose and whether multiple infusions are required according to the condition of the subject

Primary Outcome Measures

Name	Time	Method
AE	3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)	Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities according to the Common Adverse Event Evaluation Standard NCI CTCAE version 5.0

Secondary Outcome Measures

Name	Time	Method
Disease remission/response/improvement rates	3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)	Disease remission/response/improvement rates at 28 days, 2 months, and 3 months after administration.
anti-CAR antibody	3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)	The positive rate of human anti-CAR antibody at each time point.
Cmax	3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)	The maximum amplified concentration (Cmax) of UTAA09 injection in peripheral blood after administration, the time to reach the maximum concentration (Tmax), and the area under the curve AUC0-28d at 28 days and the area under the curve AUC0-90d at 90 days
CD19-positive cells	3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)	The content of CD19-positive cells in peripheral blood after UTAA09 injection administration: the proportion and absolute value of CD19-positive cells in peripheral blood at each time point; Concentration levels of CAR-T-associated serum cytokines.

Trial Locations

Locations (1)

PersonGen.Anke Cellular Therapeutice Co., Ltd; 🇨🇳 Hefei, China