## Protocol Section
### Identification Module
**NCT ID:** NCT06417398

**Brief Title:** Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

**Official Title:** Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

#### Organization Study ID Info
**ID:** PG-005
#### Organization
**Class:** INDUSTRY
**Full Name:** PersonGen BioTherapeutics (Suzhou) Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-27
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** PersonGen BioTherapeutics (Suzhou) Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

**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

### Conditions Module

**Conditions:**

- Systemic Lupus Erythematosus

- Idiopathic Inflammatory Myopathies

- Systemic Sclerosis

- Sjogren's Syndrome

- Rheumatoid Arthritis

- Immune Thrombocytopenia

- Primary Biliary Cholangitis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Biological: T cell injection targeting CD19 chimeric antigen receptor

**Label:** T cell injection targeting CD19 chimeric antigen receptor

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- T cell injection targeting CD19 chimeric antigen receptor

**Description:** 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.

**Name:** T cell injection targeting CD19 chimeric antigen receptor

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** AE

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

#### Secondary Outcomes

**Description:** UTAA09 injection was administered in peripheral bloodCmax

**Measure:** Peak Plasma Concentration (Cmax）

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

**Description:** UTAA09 injection was administered in peripheral blood

**Measure:** Area under the plasma concentration versus time curve (AUC)

**Time Frame:** 3 months after cell reinfusion/28d after cell reinfusion

**Description:** The proportion and absolute value of CD19 positive cells in peripheral blood at each time point

**Measure:** Content of CD19 positive cells in peripheral blood

**Time Frame:** every visits after infusion up to 2 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** njwujian@163.com

**Name:** jian wu, Doctor

**Phone:** 15358805676

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** The First Affiliated Hospital of Soochow University

**Name:** jian wu, Doctor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001172

- Term: Arthritis, Rheumatoid

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000001791

- Term: Blood Platelet Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000095542

- Term: Cytopenia

- ID: D000012871

- Term: Skin Diseases

- ID: D000014987

- Term: Xerostomia

- ID: D000012466

- Term: Salivary Gland Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000015352

- Term: Dry Eye Syndromes

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001649

- Term: Bile Duct Diseases

- ID: D000001660

- Term: Biliary Tract Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000011696

- Term: Purpura, Thrombocytopenic

- ID: D000011693

- Term: Purpura

- ID: D000001778

- Term: Blood Coagulation Disorders

- ID: D000057049

- Term: Thrombotic Microangiopathies

- ID: D000006474

- Term: Hemorrhagic Disorders

- ID: D000006470

- Term: Hemorrhage

- ID: D000012877

- Term: Skin Manifestations

- ID: D000002780

- Term: Cholestasis, Intrahepatic

- ID: D000002779

- Term: Cholestasis

- ID: D000008107

- Term: Liver Diseases

- ID: D000008103

- Term: Liver Cirrhosis

- ID: D000005355

- Term: Fibrosis

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M15664

- Name: Sjogren's Syndrome

- Relevance: HIGH

- As Found: Sjogren's Syndrome

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M15415

- Name: Sclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: HIGH

- As Found: Autoimmune Diseases

- ID: M16680

- Name: Thrombocytopenia

- Relevance: HIGH

- As Found: Thrombocytopenia

- ID: M15412

- Name: Scleroderma, Systemic

- Relevance: HIGH

- As Found: Systemic Sclerosis

- ID: M25560

- Name: Scleroderma, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: LOW

- As Found: Unknown

- ID: M11177

- Name: Lupus Erythematosus, Systemic

- Relevance: HIGH

- As Found: Systemic Lupus Erythematosus

- ID: M6002

- Name: Cholangitis

- Relevance: HIGH

- As Found: Cholangitis

- ID: M12172

- Name: Myositis

- Relevance: HIGH

- As Found: Idiopathic Inflammatory Myopathies

- ID: M18945

- Name: Purpura, Thrombocytopenic, Idiopathic

- Relevance: HIGH

- As Found: Immune Thrombocytopenia

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11103

- Name: Liver Cirrhosis

- Relevance: LOW

- As Found: Unknown

- ID: M11105

- Name: Liver Cirrhosis, Biliary

- Relevance: HIGH

- As Found: Primary Biliary Cholangitis

- ID: M14547

- Name: Purpura

- Relevance: LOW

- As Found: Unknown

- ID: M14550

- Name: Purpura, Thrombocytopenic

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5072

- Name: Blood Platelet Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3170

- Name: Cytopenia

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17724

- Name: Xerostomia

- Relevance: LOW

- As Found: Unknown

- ID: M15285

- Name: Salivary Gland Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: LOW

- As Found: Unknown

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4935

- Name: Bile Duct Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4946

- Name: Biliary Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M28682

- Name: Thrombotic Microangiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M15680

- Name: Skin Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M6019

- Name: Cholestasis

- Relevance: LOW

- As Found: Unknown

- ID: M6020

- Name: Cholestasis, Intrahepatic

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: T5565

- Name: Systemic Scleroderma

- Relevance: LOW

- As Found: Unknown

- ID: T4683

- Name: Primary Biliary Cholangitis

- Relevance: HIGH

- As Found: Primary Biliary Cholangitis

- ID: T3040

- Name: Inclusion Body Myositis

- Relevance: HIGH

- As Found: Inflammatory Myopathies

- ID: T3021

- Name: Immune Thrombocytopenia

- Relevance: HIGH

- As Found: Immune Thrombocytopenia

- ID: T3007

- Name: Idiopathic Thrombocytopenic Purpura

- Relevance: HIGH

- As Found: Immune Thrombocytopenia

- ID: T3001

- Name: Idiopathic Inflammatory Myopathy

- Relevance: HIGH

- As Found: Idiopathic Inflammatory Myopathies

### Condition Browse Module - Meshes

- ID: D000012859

- Term: Sjogren's Syndrome

- ID: D000009220

- Term: Myositis

- ID: D000002761

- Term: Cholangitis

- ID: D000008105

- Term: Liver Cirrhosis, Biliary

- ID: D000013921

- Term: Thrombocytopenia

- ID: D000016553

- Term: Purpura, Thrombocytopenic, Idiopathic

- ID: D000008180

- Term: Lupus Erythematosus, Systemic

- ID: D000012595

- Term: Scleroderma, Systemic

- ID: D000001327

- Term: Autoimmune Diseases

### Misc Info Module

- Version Holder: 2024-05-31
