An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease

NCT06379646 | Recruiting

• 1 other identifier: YTS109-003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease

Conditions

Systemic Lupus Erythematosus; Systemic Sclerosis; Inflammatory Myopathy; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antiphospholipid Syndrome; Sjogren's Syndrome

Outcome Measures

Primary Outcomes (7)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.

  3 months for safety measurements during the treatment assessment period

• Efficacy outcomes for SLE

  SLE Response index 4(SR-4) response: Min/Max Value: Not specife: a decrease in score indicates improvement: hicher scores indicate worse outcome

  3 months for efficacy measurements during the treatment assessment period

• Efficacy outcomes for Sjogren's Syndrome

  Sjogren's tool for assessing response (STAR): Min/Max Value: Not specified: a decrease n score indicates improvement: higher scores indicate worse outcome

  3 months for efficacy measurements during the treatment assessment period

• Efficacy outcomes for Systemic Sclerosis

  ACR-CRISS score (CRISS score ≥0.6 improvement, \< 0.6 no improvement) and modified CRISS score (rCRISS score) (percentage of patients with at least 3 of the 5 core items of ACR-CRISS improved by a certain percentage (e.g. 25%, except FVC (5%))

  3 months for efficacy measurements during the treatment assessment period

• Efficacy outcomes for Inflammatory Myopathy

  Total lmprovement Score (TlS):Min/Max Value: Not specified; an increase in score indicates improvement, higher scores indicate better outcome

  3 months for efficacy measurements during the treatment assessment period

• Efficacy outcomes for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

  Birmincham vascultis activity score (BVAS) scoreMin/Max Value: 0 to 63: an increase in score indicates worsening condition: higher cores indicate: Worse Outcome

  3 months for efficacy measurements during the treatment assessment period

• Efficacy outcomes for Antiphospholipid Syndrome

  Evaluaton of new thromboss as an indicator of relapsed/refractory/catastrophic Antiphostholpid Syndrome higher scores lndicate worse outcome (indicates procression of thesyndrome).

  3 months for efficacy measurements during the treatment assessment period

Secondary Outcomes (10)

• Peak Plasma Concentration (Cmax) of YTS109

  3 and 6 months

• Time to Peak (Tmax) of YTS109

  3 and 6 months

• Area under the plasma concentration versus time curve (AUC) of YTS109

  3 and 6 months

• PD parameters

  3 and 6 months

• Efficacy outcomes for SLE

  6 months for efficacy measurements during the treatment assessment period

Study Arms (1)

YTS109

EXPERIMENTAL

YTS109 cell injection

Other: YTS109

Interventions

YTS109 OTHER

Subjects will receive YTS109 Cell Injection(3E6STAR+T cell/kg) once in this study.

YTS109

Eligibility Criteria

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

You may qualify if:

• Age ranges from 18 to 65 years old (including threshold), regardless of gender.
• Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.
• The functions of important organs meet the following requirements:
• Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109/L; Hemoglobin ≥60g/L;
• Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;
• Renal function: creatinine clearance (CrCl) ≥30 ml/minute;
• Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;
• Heart function: good hemodynamic stability;
• Female subjects with fertility and male subjects whose partners are women of childbearing age are required to use medically approved contraception or abstinence during the study treatment period and at least 6 months after the end ofthe study treatment period; Female subjects of childbearing age tested negative for serum HCG within 7 days before enrollment in the study and were not in lactation.
• Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
• Recurrent refractory systemic lupus erythematosus
• Complies with the classification standards of the 2019 European Union Against Rheumatology/American Society of Rheumatology (EULAR/ACR) SLE;
• Disease activity score SELENA SLEDAI≥6 with at least one Injima Lupus Assessment Group Index (BILAG-2004) category A (severe presentation) or two Category B (moderate presentation) organ scores, or both; Or disease activity score SELENA SLEDAI score ≥8;
• Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.
• Recurrent refractory sjogren's syndrome

You may not qualify if:

• People with severe drug allergy or allergic constitution;
• the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
• Subjects with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis as a result of the disease);
• Patients with cardiac dysfunction;
• Subjects with congenital immunoglobulin deficiency;
• History of malignant tumor in recent five years;
• Subjects with end-stage renal failure;
• Subjects with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis positive;
• Mental illness and severe cognitive impairment;
• Participants who had participated in other clinical trials within 3 months before enrollment;
• The duration of use of immunosuppressants that have therapeutic effects on the disease before enrollment was within five half-lives or biologics within four weeks;
• A woman who is pregnant or planning to become pregnant;
• The investigators believe that there are also subjects who could not be included in the study for other reasons.

Sponsors & Collaborators

• China Immunotech (Beijing) Biotechnology Co., Ltd.: lead
• Shanghai Changzheng Hospital: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

• Wang X, Zhang Y, Wang H, Wu X, He C, Lin S, Pang K, Li Y, Chen Y, Tang X, Liu X, Wang J, Ye S, Yan R, Guan T, Dai B, Lu J, He H, Lin L, Lu H, Li T, Zhou L, Ye L, Zhao J, Liu Y, Ta N, Wu J, Cai W, Wan Z, Zhang S, Sun R, Zhao X, Wang J, Lin Y, Ning B, Zhao Z, Tang X, Du J, Mao Z, He Y, Zheng H, Sun L, Lin X, Xu H. Allogeneic CD19-targeting T cells for treatment-refractory systemic lupus erythematosus: a phase 1 trial. Nat Med. 2025 Nov;31(11):3713-3724. doi: 10.1038/s41591-025-03899-x. Epub 2025 Aug 27.

  PMID: 40866583 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic; Myositis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antiphospholipid Syndrome; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Huji Xu, MD,Ph.D

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huji Xu

CONTACT

8602181886999; xuhuji@smmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 23, 2024
• Study Start: April 24, 2024
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)