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

NCT06361745 | Recruiting

• 1 other identifier: PG-005-6
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Idiopathic Inflammatory Myopathies; Systemic Sclerosis; IgG4 Related Disease; Primary Sjögren Syndrome

Outcome Measures

Primary Outcomes (1)

• AE

  Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities according to the Common Adverse Event Evaluation Standard NCI CTCAE version 5.0

  3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)

Secondary Outcomes (4)

• Cmax

  3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)

• CD19-positive cells

  3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)

• Disease remission/response/improvement rates

  3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)

• anti-CAR antibody

  3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)

Study Arms (1)

T cell injection targeting CD19 chimeric antigen receptor

EXPERIMENTAL

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

Biological: T cell injection targeting CD19 chimeric antigen receptor

Interventions

T cell injection targeting CD19 chimeric antigen receptor BIOLOGICAL

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.

T cell injection targeting CD19 chimeric antigen receptor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (3) Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.
• (4) Liver and kidney function, cardiopulmonary function meet the following requirements:
• Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
• Blood oxygen saturation \>91% in non-oxygen state;
• Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.
• (5) no serious mental disorders; (6) Can understand this test and have signed the informed consent.

You may not qualify if:

• Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
• Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;
• Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;
• Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
• Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;
• Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;
• Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
• Participated in other clinical studies 1 month before screening;
• Evidence of central nervous system invasion during subject screening;
• Mental patients with depression or suicidal thoughts;
• Those who received live vaccine within 28 days prior to screening;

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

PersonGen.Anke Cellular Therapeutice Co., Ltd

Hefei, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Myositis; Scleroderma, Systemic; Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases

Study Officials

• songlou yin, master

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

songlou yin, master

CONTACT

0516-85806210; yinsonglou@163.com

dongmei zhou, doctor

CONTACT

18052268809

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: UTAA09 injection

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: April 2, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)