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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 18-90 years old; - Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria. - SELENA-SLEDAI≥8. - Patients with CD19+ B-cell. - blood count (hemoglobin) at least 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; kidney function (creatinine clearance) at least 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 willing to sign a consent form signed by the patient or his/her legal/authorized representative. Who Should NOT Join This Trial: - 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 weakened immune system, 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

CD19- BCMA CAR-T cells

The intervention in this clinical trial involves a novel approach using CD19/BCMA-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. CD19/BCMA-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD19/BCMA-CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD19/BCMA-CAR T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses.

Locations (1)

District One Hospital
Beijing, Beijing Municipality, China