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

May 12, 2024 updated by: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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, 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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

(2) Expected survival time ≥3 months; (3) Subjects with recurrent/refractory autoimmune disease who have failed standard treatment or lack effective treatment, including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.

(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.

Exclusion Criteria:

  1. 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;
  2. 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;
  3. 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;
  4. Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
  5. Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;
  6. 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;
  7. Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
  8. Participated in other clinical studies 1 month before screening;
  9. Evidence of central nervous system invasion during subject screening;
  10. Mental patients with depression or suicidal thoughts;
  11. Those who received live vaccine within 28 days prior to screening;
  12. Situations considered unsuitable for inclusion by other researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: T cell injection targeting CD19 chimeric antigen receptor
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
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE
Time Frame: 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.
3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax）
Time Frame: 3 months after cell reinfusion disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
UTAA09 injection was administered in peripheral bloodCmax
3 months after cell reinfusion disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
Area under the plasma concentration versus time curve (AUC)
Time Frame: 3 months after cell reinfusion/28d after cell reinfusion
UTAA09 injection was administered in peripheral blood
3 months after cell reinfusion/28d after cell reinfusion
Content of CD19 positive cells in peripheral blood
Time Frame: every visits after infusion up to 2 years
The proportion and absolute value of CD19 positive cells in peripheral blood at each time point
every visits after infusion up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Investigators

  • Principal Investigator: Jian Wu, Doctor, The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 14, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

May 12, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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