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CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases

Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases

NCT06680388•Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

Autoimmune diseases such as systemic lupus erythematosus (SLE), diffuse cutaneous systemic sclerosis (dcSSc), antineutrophil cytoplasmic antibody (ANCA) -associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), and Sjogren's syndrome (SS) have complex etiologies and are prone to cause systemic multiple organ damage. Because patients need lifelong medication due to repeated disease recurrence, and the current treatment of the above autoimmune diseases has limited efficacy and greater side effects, so that patients bear an excessive burden of disease, therefore, there is an urgent need to explore safer and more effective treatment. Several autologous CAR-T products targeting CD19 have been marketed for the treatment of B-cell hematological malignancies. Depletion of B cells to suppress abnormal immune responses is also currently one of the popular strategies for the treatment of antibody-mediated autoimmune diseases, and many clinical studies of CAR-T against autoimmune diseases are still ongoing. Therefore, a dose escalation trial is planned to evaluate the safety, tolerability, and preliminary efficacy of autologous CD19 CAR-T in patients with relapsed/refractory autoimmune diseases.

Detailed Description

This study is a single-center, open, exploratory clinical trial designed to evaluate the safety and efficacy of autologous CD19 CAR-T in the treatment of relapsed/refractory autoimmune disease. The study will adopt the traditional dose escalation model "3+3" design, set up 3 dose groups, with 0.5×10\^6 CAR+T cells /kg as the initial dose to increase, observe DLT, and conduct a 24-month safety and efficacy follow-up after cell infusion to observe the safety of autologous CD19 CAR-T. At the same time, preliminary efficacy evaluation was carried out.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1、aged 18 to 65 years (including 18 and 65 years), male or female;
•2、Special criteria for different indications:
•2.1 Subjects with relapsed/refractory moderate to severe SLE must meet the following criteria:
•1\) diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE;
•2\) positive antinuclear antibody (ANA) (titer ≥ 1:80), and/or positive anti-dsDNA -antibody, and/or positive anti-Sm antibody at screening;
•3\) moderate to severe activity is defined as: SLEDAI-2000 ≥ 8 points at screening; if there is a score of low complement and/or anti-dsDNA antibody, the score for clinical symptoms of SLEDAI-2000 (except low complement and/or anti-ds-DNA antibody) needs to be ≥ 6 points;
•4\) stable standard treatment regimen for at least 6 months in the history of SLE before screening, and the disease remains active for at least 2 months before screening. Standard treatment regimen refers to stable use of any of the following drugs (alone or in combination): glucocorticoids (≤ 20 mg/day prednisone or equivalent), antimalarials (hydroxychloroquine ≤ 400 mg/day, chloroquine ≤ 500 mg/day), non-steroidal anti-inflammatory drugs (NSAIDs), biologics (rituximab, belimumab, tatacept) and other immunosuppressive agents or immunomodulators, including mycophenolate mofetil (≤ 2 g/day), azathioprine (≤ 2 mg/kg/day), methotrexate (≤ 20 mg/week);
•2.2 Subjects with relapsed/refractory dcSSc were required to meet the following criteria:
•1\) diagnosis of SSc according to the 2013 EULAR/ACR classification criteria for systemic sclerosis (SSc);
•2\) diffuse cutaneous manifestations according to the 1988 LeRoy et al criteria, ie, extensive skin fibrosis with proximal elbow and/or knee skin involvement;
+26 more criteria

Exclusion Criteria

•1\. patients with previous or concurrent other active malignancies, including tumor-associated polymyositis/dermatomyositis. Cured or at least 2 years without recurrence of cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer or radical treatment of local prostate cancer, ductal carcinoma in situ after radical resection;
•2\. combined with severe lung disease in the past 3 months, such as moderate to severe pulmonary hypertension (mean pulmonary arterial pressure \> 60 mmHg by echocardiography), oxygen therapy with oxygen mask or non-invasive or invasive ventilator-assisted respiration during screening;
•3\. IgA, IgG, IgM below the lower limit of normal (LLN) at screening;
•4\. patients who have used any of the following drugs or treatments within the specified time:
•1\) B cell depletion therapy within 1 month before screening and no treatment failure as assessed by clinicians, including targeted CD20, CD22, CD52, CD38, BCMA monoclonal antibody or bispecific antibody;
•2\) high-dose human intravenous immunoglobulin within 1 month before screening; -3) Use of therapeutic doses of glucocorticoids (prednisone ≥ 20 mg/day or equivalent doses of other corticosteroids) within 24 hours before Qinglin pretreatment;
•4\) Has received corticosteroid pulse therapy (defined as doses ≥ 500 mg/day prednisone or equivalent doses of other corticosteroids) within 2 weeks;
•5\) has received taitacept within 2 weeks prior to Screening or belimumab within 3 weeks;
•5\. Patients with a history of severe central nervous system disease or related symptoms (excluding trigeminal nerve disease alone) in the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease and other central nervous system diseases, as well as epilepsy, convulsions, aphasia, dementia and other symptoms;
•6\. Lupus crisis occurred within 3 months before screening, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc.;
+16 more criteria

Locations (1)

Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

November 15, 2024

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Autoimmune Diseases

Interventions

Drug：CD19 CAR-T

DRUG

Contacts

wang ying

CONTACT

022-23909095 wangying1@ihcams.ac.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases

Inclusion Criteria

Exclusion Criteria

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