CAR-T Therapy for Refractory Autoimmune Diseases

NCT07059169 | Recruiting

• 1 other identifier: JY CT-24-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19 CAR-T in the treatment of refractory autoimmune diseases.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events(AE) after infusion

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

  Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

• Maximal Tolerated Dose(MTD)

  MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.

  Up to 28 days after infusion

Study Arms (1)

CD19 CAR-T for the treatment of refractory autoimmune diseases

EXPERIMENTAL

CD19 CAR-T for the Treatment of refractory autoimmune diseases subjects who meet the inclusion criteria will receive intravenous JY231 injection. JY231 injection infusion will produce CAR-T cells in the body.

Drug: JY231 (JY231 injection)

Interventions

JY231 (JY231 injection) DRUG

JY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion.

CD19 CAR-T for the treatment of refractory autoimmune diseases

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old, regardless of gender, signed with informed consent (ICF).
• Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).
• Patients who have been treated with ≥ 2 immunosuppressive agents for 3 months, or require ≥ 15mg glucocorticoids to maintain stable condition, or are intolerant to standard treatment, or have relative contraindications, and whose disease activity meets the following criteria:
• For SLE patients, SLEDAI ≥ 8 points;
• For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;
• For SSc patients, the modified skin score (mRSS) score ranges from 10 to 35 (including cutoff values) and is associated with interstitial pneumonia (ILD);
• For DM patients, diagnosed for at least 1 year;
• For ANCA-AAV patients, Birmingham Vasculitis Activity Score(BVAS) score ≥ 15 and ANCA antibodies.
• Eastern Cooperative Oncology Group(ECOG) 0-1 points;
• The evaluation of important organ functions meets the following conditions:
• Blood count: hemoglobin ≥ 60g/L, platelet count ≥ 30 × 109/L;
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormalities observed on electrocardiogram;
• Renal function: estimated glomerular filtration rate(eGFR) ≥ 30 mL/min/1.73m2;
• Liver function: Aspartate Aminotransferase(AST) and Alanine Transaminase(ALT) ≤ 3.0 upper limit of normal(ULN), total bilirubin ≤ 2.0 ULN;
• Pulmonary function: diffusion capacity of the lung for carbon monoxide(DLCO) ≥ 40% expected value; forced vital capacity(FVC) ≥ 50% of expected value;

You may not qualify if:

• Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
• Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;
• Active or uncontrollable infections that require systemic treatment within the first week of screening;
• Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;
• Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus(HBV) DNA titer in peripheral blood is greater than the normal reference value; Or hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer detection greater than the normal reference range; Or positive for human immunodeficiency virus (HIV) antibodies; Or those who test positive for syphilis; Or positive for cytomegalovirus (CMV) DNA detection;
• Received live vaccine within 4 weeks prior to screening;
• Pregnancy test positive individuals;
• Patients with malignant tumors and other malignant diseases before screening, in addition to fully treated cervical cancer in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
• Screening patients who have participated in other clinical trials within the first three months;
• Other researchers believe that it is not suitable to participate in this study.

Sponsors & Collaborators

• LiangZou: lead

Study Sites (1)

Wuhan No.1 Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Liang Zou, Doctor

CONTACT

+86 186 0270 1800; zozozou@qq.com

Xiaoya Du

CONTACT

+86 27 8533 2028

Study Design

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

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)