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New treatment option for Systemic Lupus Erythematosus
Official title Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT06350110
What this study is testing
What is CD19- BCMA CAR-T cells?
CD19- BCMA CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as EB-BH2024-2.
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 study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 90
You may be able to join if
- 18-90 years old;
- Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria.
- SELENA-SLEDAI≥8.
- Patients with CD19+ B-cell.
- Hemoglobin≥85 g/L.
You likely can't join if
- Renal disease: severe lupus nephritis (serum creatinine \> 2.5 mg/dL or 221 μmol/L) within 8 weeks --Prior to leukapheresis, or people who need...
- CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis...
- Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.
- Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;
- Received immunosuppressive therapy within 1 week prior to leukapheresis.
- Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus.
See the full eligibility criteria
- 18-90 years old;
- Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria.
- SELENA-SLEDAI≥8.
- Patients with CD19+ B-cell.
- Hemoglobin≥85 g/L.
- WBC≥2.5×10\^9/L.
- NEUT≥1×10\^9/L.
- BPC≥50×10\^9/L.
- AST/ALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL/min; blood bilirubin ≤2.0 mg/dl; echocardiography indicates that the ejection fraction is ≥50%.
- Adequate venous access for apheresis, and no other contraindications for leukapheresis.
- Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline.
- people agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.
- Agree to attend follow-up visits as required.
- Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.
- Renal disease: severe lupus nephritis (serum creatinine \> 2.5 mg/dL or 221 μmol/L) within 8 weeks --Prior to leukapheresis, or people who need hemodialysis.
- CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.
- Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.
- Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;
- Received immunosuppressive therapy within 1 week prior to leukapheresis.
- Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus.
- Patients with syphilis infection.
- The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening.
- Received live vaccine treatment within 4 weeks prior to screening.
- Severe allergies or hypersensitivity.
- Contraindication to cyclophosphamide in combination with fludarabine.
- people who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the...
- Cannula or drainage tubes other than central venous catheters.
- Pregnant or lactating women, or people who plan to have children within 1 year of treatment;
- people with prior CD19 or BCMA-targeted therapy.
- Participated in any clinical study within 3 months prior to enrollment.
- people with malignant tumour, except for Non-melanoma Skin Cancer with PFS\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.
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, 18 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.