Tests GC012F cell treatment in adults with hard-to-treat lupus

Trial details

Who runs it

RenJi Hospital

Trial code

NCT05858684

Record updated

1 June 2026

Original description

This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.Read full original descriptionShow less

Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients

This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.

Inclusion: 18-70 years old; Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria; LLDAS response criteria are not achieved after administration with at least two immunosuppressants (including, but not limited to, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, ciclosporin and iguratimod) and/or at least one approved biological agent for more than 6 months; 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: Received immunosuppressive therapy within 1 week prior to leukapheresis; Received live vaccine treatment within 4 weeks prior to screening; 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; Subjects with prior CD19 or BCMA-targeted therapy; Participated in any clinical study within 3 months prior to enrollment; 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 history of present illness of vital organs such as heart, liver, kidney and blood and endocrine system; Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers; 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; Severe allergies or hypersensitivity; Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer; 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; Contraindication to cyclophosphamide in combination with fludarabine; 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; Any situations that the investigator believes the patients are not suitable for the study.

ClinicalTrials.gov NCT05858684