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

Launched by ESSEN BIOTECH · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment using a type of engineered immune cells called CAR T cells to help patients with systemic lupus erythematosus (SLE) who have not responded to other treatments. The goal is to find the highest safe dose of the treatment, known as BH002, which targets specific proteins on certain immune cells. This study is currently open for enrollment and is looking for participants aged 18 to 90 who meet specific health criteria, including having a certain level of lupus severity and sufficient blood counts.

Participants in this trial will receive the CAR T cell treatment and will be monitored to see how well they tolerate it and if it helps with their condition. Importantly, participants must not have severe kidney disease or active infections and should be able to attend follow-up visits. Women of childbearing age will need to take precautions to avoid pregnancy during the study. This trial aims to offer a new hope for those struggling with difficult-to-treat lupus by exploring an innovative therapy that may improve their quality of life.

Gender

ALL

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 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.