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New treatment option for IgG4 Related Disease
Official title Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease
ClinicalTrials.gov ID: NCT07148791
What this study is testing
What is Anti-BCMA-CD19 CAR-T cells?
Anti-BCMA-CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for igg4 related disease.
Also referred to as BC19, CD19/BCMA dual-target CAR-T cell therapy.
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
- The goal of this clinical trial is to test the safety and potential benefit of a new immune cell therapy called anti-BCMA-CD19 CAR-T cells in adults (18-75 years) with IgG4-related disease (IgG4-RD) that has come back or not improved after standard treatments such as glucocorticoids or rituximab. The main questions this study aims to answer are: What medical problems (side effects) occur after receiving anti-BCMA-CD19 CAR-T cell therapy?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 26 weeks
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 75
You may be able to join if
- To participate, people must meet all of the following criteria:
- Aged 18 to 75 years, inclusive, regardless of sex.
- Meet the 2019 ACR/EULAR classification criteria for IgG4-related disease.
- Involvement of two or more important systems/sites (including but not limited to the pancreas, bile ducts, kidneys and dura mater).
- Relapsed or refractory IgG4-RD: The disease either remains active after 3 months of glucocorticoid and/or rituximab therapy or relapses within 6...
You likely can't join if
- people will be excluded if any of the following criteria are met:
- History of severe drug allergy or allergic constitution.
- Current or suspected uncontrollable or treatment-requiring fungal, bacterial, viral or other infections.
- Central nervous system disease (excluding disease-related epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis or...
- Cardiac insufficiency that precludes participation.
- Congenital immunoglobulin deficiency.
See the full eligibility criteria
- To participate, people must meet all of the following criteria:
- Aged 18 to 75 years, inclusive, regardless of sex.
- Meet the 2019 ACR/EULAR classification criteria for IgG4-related disease.
- Involvement of two or more important systems/sites (including but not limited to the pancreas, bile ducts, kidneys and dura mater).
- Relapsed or refractory IgG4-RD: The disease either remains active after 3 months of glucocorticoid and/or rituximab therapy or relapses within 6 months post-treatment.
- Important organ function meeting the following conditions:
- Bone marrow: (i) neutrophil count ≥1×10\^9/L (excluding disease-related neutropenia); (ii) hemoglobin ≥60 g/L.
- Hepatic function: ALT≤3×ULN (elevation caused by disease may be excluded); AST≤3×ULN (elevation caused by disease may be excluded); TBIL≤1.5×ULN (elevation caused by disease may be excluded).
- Renal function: creatinine clearance (Cockcroft-Gault formula) ≥30 ml/min (excluding acute decline due to disease).
- Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN
- Cardiac function: stable hemodynamics.
- Women of childbearing potential and male people with partners of childbearing potential must use medically accepted contraception or abstain during study treatment and for at least 12 months after the end of treatment...
- Voluntary participation in this clinical study with signed informed consent and willingness to comply with study procedures and follow-up.
- Patent superficial peripheral veins adequate for intravenous infusion.
- people will be excluded if any of the following criteria are met:
- History of severe drug allergy or allergic constitution.
- Current or suspected uncontrollable or treatment-requiring fungal, bacterial, viral or other infections.
- Central nervous system disease (excluding disease-related epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis).
- Cardiac insufficiency that precludes participation.
- Congenital immunoglobulin deficiency.
- Congenital malformation or nutritional disorder causing severe organ impairment.
- History of malignancy within the past five years.
- End-stage renal failure.
- Positive hepatitis B surface antigen and hepatitis B core antibody with HBV-DNA titers above the assay limit of detection; positive hepatitis C antibody with HCV-RNA positivity; positive human immunodeficiency virus...
- Psychiatric disorders or severe cognitive impairment.
- Participation in other clinical trials within three months before enrollment.
- Receipt of any investigational drug within 12 weeks before screening or within five half-lives of the agent (whichever is longer).
- Pregnant or intending to become pregnant.
- Any other reason deemed by the investigator to preclude enrollment.
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 study runs about 26 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 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.