CAR T Cell Therapy for Refractory Systemic Lupus Erythematosus
T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement
This study is testing a new CAR T cell therapy to see if it can help people with hard-to-treat systemic lupus erythematosus by targeting certain immune cells.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Essen Biotech Academic / other |
| Drugs / interventions | CAR-T, cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06350110 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of fourth-generation CAR T cells targeting BCMA and CD19 to treat patients with refractory systemic lupus erythematosus (SLE). It aims to determine the highest tolerable dose of BH002 injection in a single-group design. The approach focuses on eradicating abnormal B cells responsible for autoantibody production, potentially restoring normal immune function. The study includes patients aged 18-90 who meet specific eligibility criteria related to their SLE condition and overall health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-90 with refractory systemic lupus erythematosus who meet specific clinical criteria.
Not a fit: Patients with severe lupus nephritis or other significant renal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option that allows patients to achieve remission from SLE without the need for ongoing medication.
How similar studies have performed: While CAR T cell therapy has shown promise in other conditions, this specific application for systemic lupus erythematosus is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. * Subjects 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. Exclusion Criteria: * Renal disease: severe lupus nephritis (serum creatinine \> 2.5 mg/dL or 221 μmol/L) within 8 weeks --Prior to leukapheresis, or subjects 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. * Subjects 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 infusion. * Cannula or drainage tubes other than central venous catheters. * Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment; * Subjects with prior CD19 or BCMA-targeted therapy. * Participated in any clinical study within 3 months prior to enrollment. * Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.
Where this trial is running
Beijing, Beijing Municipality
- District One Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Rhoda M Smith, Phd
- Email: clinical-trials@essen-biotech.com
- Phone: +12077706670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.