Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus

NCT05846347 | Unknown Phase 1

• 1 other identifier: GC012F-614
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CAR-T

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 level： 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) once 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;
• Active organ involvement;
• Hemoglobin≥85 g/L;
• WBC≥2.5×10\^9/L
• NEUT≥1×10\^9/L;
• PLT≥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 prohibited drugs to treat active nephritis 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

• Zhejiang University: lead
• Gracell Biotechnologies (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital,College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Study Officials

• He Huang

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Zhihong Liu

  Zhejiang university school of medicine

  PRINCIPAL INVESTIGATOR

• Jin Lin

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, MD

CONTACT

+8615957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: 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: April 26, 2023
• First Posted: May 6, 2023
• Study Start: May 15, 2023
• Primary Completion: October 19, 2023
• Study Completion: April 19, 2025
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)