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New treatment option for Systemic Lupus Erythematosus
Official title CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT06941129
What this study is testing
What is UCAR T-cell?
UCAR T-cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
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
- CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Common
- Age ≥ 18 years old (inclusive), regardless of gender.
- Positive expression of CD19 or BCMA on peripheral blood B cells confirmed by flow cytometry.
- Functional requirements for major organs are as follows（Except for abnormalities related to autoimmune disease activity）: 1) Bone marrow function...
- ECOG score 0-2.
You likely can't join if
- people with a history of severe drug allergies or allergic tendencies.
- Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
- people with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain...
- people with insufficient cardiac function.
- people with congenital immunoglobulin deficiencies.
- History of malignancy within five years.
See the full eligibility criteria
Who can join
- Common
- Age ≥ 18 years old (inclusive), regardless of gender.
- Positive expression of CD19 or BCMA on peripheral blood B cells confirmed by flow cytometry.
- Functional requirements for major organs are as follows（Except for abnormalities related to autoimmune disease activity）: 1) Bone marrow function must meet: A. Neutrophil count ≥ 1×109/L (no colony-stimulating factor...
- ECOG score 0-2.
- Female people of childbearing potential and male people with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after...
- Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. Disease-Specific Refractory/Relapsed Systemic Lupus Erythematosus:
- SLE meeting the 2019 the American College of Rheumatology (ACR) /European League Against Rheumatism (EULAR) and classification criteria.
- Disease activity score SLEDAI-2000 ≥ 8; or with significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of class III or IV, with or without class V, with an NIH activity index...
- Definition of refractory or relapsing disease: lack of response after more than 6 months of conventional therapy, or recurrence of disease activity after remission. Conventional therapy is defined as treatment with...
- Scleroderma fulfilling the 2013 ACR classification criteria.
- Positive scleroderma-related antibodies.
- Presence of diffuse cutaneous sclerosis or active interstitial lung disease (high-resolution computed tomography (HRCT) showing ground-glass opacities).
- Definition of relapsed/refractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more...
- Definition of progressive: Rapid skin progression (mRSS increase \> 25%); or progression of lung disease (forced vital capacity (FVC) decrease by 10%, or FVC decrease by more than 5% with diffusing capacity of the lung...
- Inflammatory myopathy fulfilling the 2017 EULAR/ACR classification criteria (including Dermatomyositis (DM), Polymyositis (PM), Anti-Synthetase Syndrome (ASS), and Necrotizing Myopathy (NM)).
- Muscle involvement with Manual Muscle Testing-8 (MMT-8) score less than 142 and at least two abnormalities found among the following five core measurements (Physician Global Assessment (PhGA), Patient Global Assessment...
- Definition of relapsed/refractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more...
- Definition of progressive: Rapid progression of interstitial lung disease within a short period. Note: Meeting either criterion 4 or 5 is sufficient. Refractory/Relapsed ANCA-Associated Vasculitis:
- ANCA-Associated Vasculitis fulfilling 2022 ACR/EULAR criteria, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.
- Positive ANCA-associated antibodies (MPO-ANCA or PR3-ANCA positive).
- The Birmingham Vasculitis Activity Scale (BVAS) ≥ 15 points (a total score of 63 points), indicating active vasculitis.
- Definition of refractory/relapsed: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission., or disease recurrence after remission. Definition of conventional treatment: the use...
- Diagnosis of connective tissue disease established according to the latest classification criteria, including but not limited to systemic lupus erythematosus, primary Sjögren's syndrome, antiphospholipid syndrome, and...
- Confirmed diagnosis of connective tissue disease-associated thrombocytopenia, with platelet count \<30 × 10\^9/L, or \<50 × 10\^9/L accompanied by a bleeding tendency.
- Bone marrow morphology consistent with immune thrombocytopenia.
- Prior treatment with at least one course of corticosteroid pulse therapy, or high-dose corticosteroids in combination with one or more immunosuppressants (including biologics) for at least 3 months, without achieving...
What rules you out
- people with a history of severe drug allergies or allergic tendencies.
- Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
- people with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous...
- people with insufficient cardiac function.
- people with congenital immunoglobulin deficiencies.
- History of malignancy within five years.
- people with end-stage renal failure(LN is excluded).
- people who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>ULN; people positive for hepatitis C virus (HCV) antibody and peripheral blood HCV...
- people with psychiatric disorders and severe cognitive impairments;
- people who have participated in other clinical trials within the past 3 months prior to enrollment.
- people who have received immunosuppressive agents or biologics with therapeutic effects for indications within 5 half-life prior to enrollment.
- Pregnant women or women planning to conceive.
- people whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, 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.