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Tests treatment safety and results for Systemic Lupus Erthematosus
Official title Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT06828042
What this study is testing
What is anti-CD19 CAR T cell therapy?
anti-CD19 CAR T cell therapy is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for systemic lupus erthematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Common
- Age between 18-80 years (inclusive), male or female.
- Positive expression of CD19 on peripheral blood B cells by flow cytometry.
- Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity...
- Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If...
You likely can't join if
- History of severe drug allergies or allergic constitution.
- Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Central nervous system (CNS) diseases caused by autoimmune or non-autoimmune conditions, including epilepsy, psychiatric disorders, organic brain...
- Dysfunction of major organs not meeting the following criteria (exceptions allowed if abnormalities are caused by autoimmune disease): a. Bone marrow...
- people with congenital immunoglobulin deficiencies.
- History of malignancy within the past five years.
See the full eligibility criteria
Who can join
- Common
- Age between 18-80 years (inclusive), male or female.
- Positive expression of CD19 on peripheral blood B cells by flow cytometry.
- Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of...
- Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must...
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment...
- Willing to participate in the trial and sign the informed consent form. Disease-Specific
- Systemic Lupus Erythematosus (SLE):
- Meets the 2019 EULAR/ACR classification criteria for SLE.
- ANA titer ≥1:80, or positive for anti-dsDNA and/or anti-Sm antibodies.
- Disease activity score (SLEDAI-2000) ≥8.
- Sjögren's Syndrome:
- Meets the 2002 AECG criteria or the 2016 ACR/EULAR classification criteria for primary Sjögren's syndrome.
- Disease activity score (ESSDAI) ≥5.
- Positive for anti-SSA/Ro antibodies.
- Systemic Sclerosis (SSc):
- Meets the 2013 EULAR/ACR classification criteria for systemic sclerosis.
- Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.
- At screening, mRSS \>10; and/or active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) \<70% of predicted...
- Idiopathic Inflammatory Myopathies (IIM):
- Meets the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).
- For patients with muscle involvement: a. MMT-8 score \<142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25...
- Positive for myositis-specific antibodies.
- ANCA-Associated Vasculitis (AAV):
- Meets the 2022 ACR/EULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.
- Positive for ANCA antibodies (current or historical).
- Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.
- Refractory Antiphospholipid Syndrome (APS):
- Meets the 2023 ACR/EULAR diagnostic criteria for antiphospholipid syndrome.
- Positive for medium-to-high titers of antiphospholipid antibodies (LA, anti-β2-GP1, or ACL IgG/IgM), with at least two positive results within 3 months.
- Definition of refractory APS: Disease remains active or relapses after remission, despite 6 months of conventional therapy, including: Anticoagulants (warfarin or standard treatment with vitamin K antagonists...
- Catastrophic APS (CAPS): Must meet all four criteria: a. Involvement of three or more organs, systems, and/or tissues. b. Symptoms occurring within one week. c. Histological evidence of small vessel occlusion in at...
What rules you out
- History of severe drug allergies or allergic constitution.
- Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Central nervous system (CNS) diseases caused by autoimmune or non-autoimmune conditions, including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis.
- Dysfunction of major organs not meeting the following criteria (exceptions allowed if abnormalities are caused by autoimmune disease): a. Bone marrow function: White blood cell count ≥3×10⁹/L. Neutrophil count ≥1×10⁹/L...
- people with congenital immunoglobulin deficiencies.
- History of malignancy within the past five years.
- people with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA levels exceeding the detection limit; positive hepatitis C virus (HCV) antibodies with...
- people with psychiatric disorders or severe cognitive impairment.
- Participation in other clinical trials within 3 months prior to enrollment.
- Previous treatment with CAR-T therapy.
- History of severe adverse reactions to cyclophosphamide or fludarabine.
- Any other reason that the investigator determine that people cannot be included in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.