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

NCT05858684 | Unknown Early Phase 1

• 1 other identifier: GC012F-615
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CAR-T Cell Therapy

Outcome Measures

Primary Outcomes (2)

• The proportion of subjects with DLT

  DLT definition is dose-limiting toxicity

  Within 28 days after GC012F injection infusion

• The proportion of subjects with adverse events

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

  Within 12 weeks after GC012F injection infusion

Secondary Outcomes (2)

• Proportion of subjects achieving SRI-4

  4, 8, 12 and 24 weeks after GC012F injection infusion

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

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

Study Arms (1)

GC012F injection (CD19-BCMA CAR-T cells)

EXPERIMENTAL

Dose escalation phase: DL-1：0.5±20%×10\^5/kg, DL1：1±20%×10\^5/kg, DL2：2±20%×10\^5/kg DL3：3±20%×10\^5/kg

Drug: GC012F injection

Interventions

GC012F injection DRUG

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

Also known as: CD19-BCMA CAR-T cells

GC012F injection (CD19-BCMA CAR-T cells)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• RenJi Hospital: lead
• Gracell Biotechnologies (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Central Study Contacts

Qiong Fu, PhD

CONTACT

13585603288; fuqiong5@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: May 11, 2023
• Primary Completion: November 10, 2023
• Study Completion: May 10, 2025
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)