CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease

NCT07193667 | Recruiting DMC

• 1 other identifier: 2024-757-2
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed/refractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.

Conditions

Relapsed/Refractory Autoimmune Diseases

Keywords

CAR-T

Outcome Measures

Primary Outcomes (1)

• chimeric status

  Detecting the chimerism in recipients' peripheral blood and bone marrow.Chimerism is generally measured in percentages(%)

  1 year after transplantation

Study Arms (1)

relapsed/refractory autoimmune diseases

EXPERIMENTAL

Drug: CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases

Interventions

CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases DRUG

This is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows: 1. Screening period (D-28 to D-6): After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria. 2. Lymphocyte depletion pretreatment (Study D-5 to Study D-3): Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen) 3. Rest and Observation (Study D-2 to Study D-1): Follow the study procedures and perform the relevant examinations during the rest and observation period. 4. Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-da

relapsed/refractory autoimmune diseases

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 18-65 years (including threshold) and gender;
• positive expression of CD19 in peripheral blood B cells as determined by flow cytometry;
• the function of vital organs meets the following requirements:
• Bone marrow function needs to meet the following requirements: a. White blood cell count ≥3×109/L; b. Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to the examination); c. Hemoglobin ≥60g/L;
• Liver function: ALT≤3×ULN (except for elevated ALT caused by inflammatory myopathy); AST≤3×ULN (except for AST elevation caused by inflammatory myopathy); TBIL≤1.5×ULN (except for Gilbert's disease).
• TBIL≤1.5×ULN (except Gilbert's syndrome, total bilirubin≤3.0×ULN);
• Renal function: creatinine clearance (CrCl) ≥ 30 ml/minute (Cockcroft/Gault formula, except for disease-induced decline in CrCl);
• Coagulation: international normalized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) ≤ 1.5 x ULN.
• Cardiac function: hemodynamic stability;
• female subjects of childbearing potential and male subjects with a partner of childbearing potential are required to use medically approved contraception or be abstinent from sexual intercourse for at least 6 months during and after study treatment; female subjects of childbearing potential must have had a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding;
• Voluntarily participate in this clinical study and sign the informed consent form, good compliance and cooperate with follow-up visits.
• Relapsed refractory systemic lupus erythematosus.
• meets the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;
• have a Disease Activity Score SLEDAI⁃2000 ≥ 6; and have at least one British Isles Lupus Assessment Group Index (BILAG-2004) Category A (severe manifestations) or two Category B (moderate manifestations) organ scores, or both; or have a Disease Activity Score SLEDAI-2000 ≥ 8;
• Definition of relapse-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.

You may not qualify if:

• A history of severe drug allergies or sensitivities;
• the presence or suspicion of fungal, bacterial, viral or other infections that are uncontrolled or require treatment
• persons with central nervous system disorders caused by ADs or not caused by ADs.
• those with intolerable cardiac function;
• subjects with congenital immunoglobulin defects.
• history of malignant tumors within the last five years.
• end-stage renal failure;
• subjects with positive Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of the test; subjects with positive antibody to Hepatitis C virus (HCV) and peripheral blood HCV RNA; subjects with positive antibody to Human Immunodeficiency Virus (HIV); and subjects with a positive test for Syphilis;
• mental illness and severe cognitive impairment;
• have participated in other clinical trials within 3 months prior to enrollment;
• immunosuppressants or biologics with a therapeutic effect for the indication within five half-lives prior to enrollment
• women who are pregnant or intend to become pregnant;
• subjects who, in the opinion of the investigator, have other reasons for not being included in the study.

Sponsors & Collaborators

• ShenZhen Cell Valley: lead
• First Affiliated Hospital of China Medical University: collaborator

Study Sites (1)

No. 155, The First Affiliated Hospital of China Medical University, Nanjing North Street, Heping District, Shenyang, Liaoning Province

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

rui sun

CONTACT

86+18810616095; sunrui@sz-cell.com

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: September 15, 2025
• First Posted: September 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The study will run from August 2025 to August 2027.
• Access Criteria: The sponsors and collaborators are able to access the IPD and supporting information, IPD relies on team collaboration , as well as continuous improvement in innovation and efficiency. Participants will share project information, including the project's objectives, statistical datas, and clinical study report.

Locations

CN (1)