Systemic Lupus Erythematosus Clinical Trial
— BAH242Official title:
T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement
Verified date | April 2024 |
Source | Essen Biotech |
Contact | JAMAL ALKHAYER |
Phone | +97333799773 |
ceo[@]essen-biotech.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 75 |
Est. completion date | December 28, 2025 |
Est. primary completion date | December 10, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | District one hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Essen Biotech |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells | Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined. | 28 days | |
Secondary | Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells | satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (COA) | 10-14 days after apheresis or thawing of cryopreserved peripheral blood mononuclear cell |
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