Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients
ConditionCAR-T Cell Therapy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRenJi Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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 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;
Trial design
Treatments tested in this trial
- GC012F injection
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
RenJi Hospital
Lead sponsor
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborator
Source ClinicalTrials.gov