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New treatment option for Autoimmune Diseases
Official title Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT06428188
What this study is testing
What is BCMA/CD19 CAR-T cells?
BCMA/CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune diseases.
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
- This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed/ Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.
- 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 21 to 90
You may be able to join if
- Expected survival time ≥3 months;
- people with recurrent/refractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to...
- Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.
- Liver and kidney function, cardiopulmonary function meet the following requirements:
- Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
You likely can't join if
- Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell...
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer...
- Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to...
- Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug...
- Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days...
- Pregnant or lactating women, and female people who plan pregnancy within 2 years after cell transfusion or male people whose partners plan pregnancy...
See the full eligibility criteria
- Expected survival time ≥3 months;
- people with recurrent/refractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic...
- Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.
- Liver and kidney function, cardiopulmonary function meet the following requirements:
- Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
- Blood oxygen saturation \>91% in non-oxygen state;
- Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the...
- No serious mental disorders;
- Can understand this test and have signed the informed consent.
- Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical...
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus...
- Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe...
- Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
- Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;
- Pregnant or lactating women, and female people who plan pregnancy within 2 years after cell transfusion or male people whose partners plan pregnancy within 2 years after cell transfusion;
- Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
- Participated in other clinical studies 1 month before screening;
- Evidence of central nervous system invasion during subject screening;
- Mental patients with depression or suicidal thoughts;
- Situations considered unsuitable for inclusion by other researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 21 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.