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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • GC012F injection

    Drug

    Each subject will receive GC012F injection (CD19-BCMA CAR-T cells) by intravenous infusion on Day 0.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: GC012F injection (CD19-BCMA CAR-T cells)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of subjects with DLT

DLT definition is dose-limiting toxicity

Time frame
Within 28 days after GC012F injection infusion
2

The proportion of subjects with adverse events

All adverse events were evaluated according to NCI-CTCAE v5.0 criteria

Time frame
Within 12 weeks after GC012F injection infusion

Secondary outcomes

1

Proportion of subjects achieving SRI-4

SELEAN-SLEDAI，BILAG，PGA

Time frame
4, 8, 12 and 24 weeks after GC012F injection infusion
2

Number of CAR-T cells and CAR gene copies in subjects'blood and bone marrow (if applicable)

Test method: flow cytometry and qPCR

Time frame
After GC012F injection infusion [day 4, 7, 10, 14 and week 4, 8, 12, 24]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Gracell Biotechnologies (Shanghai) Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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