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Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases | Clinical Trials | Clareo Health

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Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases

An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19-BCMA Dual-Target Chimeric Antigen Receptor T-Cell Therapy in Patients With Relapsed or Refractory Autoimmune Diseases

NCT07361094•Beijing Boren Hospital

View on ClinicalTrials.gov

Summary

Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to chronic inflammation and damage to organs such as the kidneys, lungs, muscles, nerves, or blood cells. Although many treatments are available, some patients do not respond adequately or experience repeated disease flares despite long-term therapy. New treatment approaches are therefore needed for patients with relapsed or refractory autoimmune diseases. This study is an exploratory clinical trial designed to evaluate the safety and potential benefits of a novel cell-based therapy called autologous CD19-BCMA dual-target CAR T-cell therapy. This treatment uses a patient's own immune cells, which are collected from the blood, modified in the laboratory to recognize specific immune cells involved in autoimmune disease, and then infused back into the patient. The study includes adult patients with certain relapsed or refractory autoimmune diseases, such as systemic lupus erythematosus, systemic sclerosis, inflammatory muscle diseases, Sjögren's syndrome, autoimmune hemolytic anemia, and multiple sclerosis. After cell collection and preparative treatment, participants will receive a single infusion of the investigational CAR T-cell therapy and will be closely monitored for safety. The main purpose of this study is to better understand the safety of this treatment, including possible side effects. The study will also explore how the disease responds to treatment over time. Participants will be followed for up to two years after treatment to assess safety and clinical outcomes. The results of this study may help researchers better understand whether this type of cell therapy could be a feasible treatment option for patients with difficult-to-treat autoimmune diseases in the future.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 to 70 years (inclusive), of any sex.
•2. Patients with failure of prior single-target CD19 or BCMA therapy, with a washout period of at least 6 months since the last treatment.
•3. Disease-specific criteria for different indications:
•3.1 Relapsed/Refractory Moderate-to-Severe Systemic Lupus Erythematosus (SLE)
•Participants must meet all of the following:
•1. Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus.
•2. At screening, positive antinuclear antibody (ANA) (titer ≥1:80), and/or positive anti-dsDNA antibody, and/or positive anti-Sm antibody.
•3. Moderate-to-severe disease activity defined as: SLEDAI-2000 score ≥8 at screening; if hypocomplementemia and/or anti-dsDNA antibody contribute to the score, the clinical SLEDAI-2000 score (excluding low complement and/or anti-dsDNA) must be ≥6.
•4. A documented history of at least 6 months of stable standard-of-care therapy for SLE prior to screening, with active disease for at least 2 months before screening. Standard therapy includes stable use (alone or in combination) of one or more of the following: glucocorticoids (≤20 mg/day prednisone or equivalent), antimalarial drugs (hydroxychloroquine ≤400 mg/day; chloroquine ≤500 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs), biologic agents (rituximab, belimumab, telitacicept), and other immunosuppressive or immunomodulatory agents including mycophenolate mofetil (≤2 g/day), azathioprine (≤2 mg/kg/day), methotrexate (≤20 mg/week), etc.
•3.2 Relapsed/Refractory Systemic Sclerosis (SSc)
+32 more criteria

Exclusion Criteria

•1\. Prior history of, or concurrent, other active malignancies, including malignancy-associated polymyositis/dermatomyositis. Exceptions include cervical carcinoma in situ, noninvasive basal cell or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ after curative surgery, provided the participant is considered cured or has been disease-free for at least 2 years.
•2.Severe pulmonary disease within the past 3 months, such as moderate-to-severe pulmonary arterial hypertension (mean pulmonary artery pressure \>60 mmHg by echocardiography), requirement for supplemental oxygen via reservoir mask at screening, or requirement for noninvasive or invasive mechanical ventilation.
•3.At screening, serum IgA, IgG, and IgM below the lower limit of normal (LLN). 4.Use of any of the following medications or therapies within the specified time windows:
•1. Use of B-cell-depleting therapy within 1 month prior to screening and assessed by the investigator as not having failed therapy, including agents targeting CD19, CD20, CD22, CD52, CD38, or BCMA (monoclonal antibodies or bispecific antibodies).
•2. High-dose intravenous human immunoglobulin (IVIG) within 1 month prior to screening.
•3. Therapeutic-dose systemic corticosteroids within 24 hours prior to lymphodepleting conditioning (prednisone \>20 mg/day or equivalent).
•4. Corticosteroid pulse therapy within 2 weeks (defined as prednisone ≥500 mg/day or equivalent).
•5. Telitacicept within 2 weeks prior to screening, or belimumab within 3 weeks prior to screening.
•5\. History of severe central nervous system (CNS) disease or related symptoms within the past 6 months (simple trigeminal neuralgia excluded), including but not limited to neuropsychiatric lupus, cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, as well as symptoms such as seizures/convulsions, aphasia, or dementia.
•6\. Lupus crisis within 3 months prior to screening, such as active CNS lupus, severe autoimmune hemolytic anemia, severe immune thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonitis or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, or other severe lupus manifestations.
+16 more criteria

Locations (1)

Beijing GoBroad Boren Hospital

Beijing, China

Key Dates

Start Date

November 6, 2025

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory Systemic Lupus ErythematosusRelapsed/Refractory Systemic SclerosisRelapsed/Refractory Idiopathic Inflammatory MyopathiesRelapsed/Refractory sjögren's SyndromeRelapsed/Refractory Autoimmune Hemolytic AnemiaRelapsed/Refractory Multiple Sclerosis

Interventions

Autologous CD19-BCMA Dual-Target CAR T-Cell Therapy

DRUG

Contacts

Yajing Zhang

CONTACT

+86 18501333856 yajing_cart66@126.com