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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05858684
Recruitment Status : Recruiting
First Posted : May 15, 2023
Last Update Posted : May 15, 2023
Sponsor:
Collaborator:
Gracell Biotechnology Shanghai Co., Ltd.
Information provided by (Responsible Party):
Qiong Fu, RenJi Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
CAR-T Cell Therapy Drug: GC012F injection Early Phase 1

Detailed Description:

Systemic lupus erythematosus (SLE) is a kind of autoimmune diseases mediated by autoantibody-forming immune complexes, which involving multiple systems and organs.

Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.

Traditional SLE treatment aims at long-term remission, while, CD19- BCMA CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in SLE.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients
Estimated Study Start Date : May 11, 2023
Estimated Primary Completion Date : November 10, 2023
Estimated Study Completion Date : May 10, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: GC012F injection (CD19-BCMA CAR-T cells)

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


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of subjects with DLT [ Time Frame: Within 28 days after GC012F injection infusion ]
    DLT definition is dose-limiting toxicity

  2. The proportion of subjects with adverse events [ Time Frame: Within 12 weeks after GC012F injection infusion ]
    All adverse events were evaluated according to NCI-CTCAE v5.0 criteria


Secondary Outcome Measures :
  1. Proportion of subjects achieving SRI-4 [ Time Frame: 4, 8, 12 and 24 weeks after GC012F injection infusion ]
    SELEAN-SLEDAI，BILAG，PGA

  2. Number of CAR-T cells and CAR gene copies in subjects'blood and bone marrow (if applicable) [ Time Frame: After GC012F injection infusion [day 4, 7, 10, 14 and week 4, 8, 12, 24] ]
    Test method: flow cytometry and qPCR


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-70 years old;
  2. Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria;
  3. SELENA-SLEDAI≥8;
  4. Patients with CD19+ B-cell;
  5. Hemoglobin≥85 g/L;
  6. WBC≥2.5×10^9/L
  7. NEUT≥1×10^9/L;
  8. BPC≥50×10^9/L;
  9. 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%;
  10. Adequate venous access for apheresis, and no other contraindications for leukapheresis;
  11. 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.
  12. Agree to attend follow-up visits as required;
  13. Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative;

Exclusion Criteria:

  1. 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;
  2. CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts;
  3. Patients with serious lesions and history of present illness of vital organs such as heart, liver, kidney and blood and endocrine system;
  4. Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;
  5. Received immunosuppressive therapy within 1 week prior to leukapheresis;
  6. Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus; Patients with syphilis infection;
  7. The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening;
  8. Received live vaccine treatment within 4 weeks prior to screening;
  9. Severe allergies or hypersensitivity;
  10. Contraindication to cyclophosphamide in combination with fludarabine;
  11. 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;
  12. cannula or drainage tubes other than central venous catheters;
  13. Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;
  14. Subjects with prior CD19 or BCMA-targeted therapy
  15. Participated in any clinical study within 3 months prior to enrollment
  16. Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer;
  17. Any situations that the investigator believes the patients are not suitable for the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05858684


Contacts
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Contact: Qiong Fu, PhD 13585603288 fuqiong5@163.com

Locations
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China, Shanghai
Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University Recruiting
Shanghai, Shanghai, China, 200001
Contact: Qiong Fu, MD    86-13585603288    fuqiong5@163.com   
Contact: Chunmei Wu, MD    86-15800605296    wuchunmei_1988@163.com   
Principal Investigator: Qiong Fu, MD         
Principal Investigator: Shuang Ye, MD         
Sponsors and Collaborators
RenJi Hospital
Gracell Biotechnology Shanghai Co., Ltd.
More Information
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Responsible Party: Qiong Fu, Professor, RenJi Hospital
ClinicalTrials.gov Identifier: NCT05858684    
Other Study ID Numbers: GC012F-615
First Posted: May 15, 2023    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases