No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
Essen Biotech · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility 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 cle…
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.
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