Status:
RECRUITING
A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Guangzhou Bio-gene Technology Co., Ltd
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to explore the safety and efficacy of CD19 CAR-T in active systemic lupus erythematosus.
Detailed Description
The prognosis of patients with active systemic lupus erythematosus (SLE) remains poor, due to two major therapeutic obstacles: (1) current treatment strategies including glucocorticoids, immunosuppres...
Eligibility Criteria
Inclusion
- Participants or their guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures, follow-up examinations and treatments specified in the study protocol, with good compliance;
- Age range from 18 to 70 years old, regardless of gender;
- Body weight ≥ 40kg;
- Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form;
- Active SLE needs to meet the following criteria at screening:
- SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points;
- Have received at least 8 weeks of standardized treatment for SLE prior to screening;
- Female participants need to have a negative pregnancy test, and participants agree to take effective contraceptive measures throughout the study.
Exclusion
- Known hypersensitivity to prednisone, immunosuppressive agents;
- Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active nephritis, hemodialysis or prednisone ≥ 100 mg/d, or equivalent glucocorticoid therapy for ≥14 days;
- Suicidal ideation within the past 6 months based on assessment by Columbia-Suicide Severity Rating Scale (C-SSRS) at screening; or any suicidal behaviors within the past 12 months or recurrent suicidal behaviors during the subject's lifetime;
- Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
- Existence of other lupus crisis within 8 weeks prior to screening;
- Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
- Previous or current diagnosis of severe vasculitis due to other diseases excluding SLE;
- History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
- Have received plasmapheresis, hemodialysis, intravenous immunoglobulin within 14 days prior to screening;
- Other autoimmune diseases requiring systemic therapy;
- Subjects with active viral hepatitis B; Subjects with positive hepatitis C virus (HCV) antibodies; Subjects with positive human immunodeficiency virus (HIV) antibodies; Sujects with positive extracellular DNA quantification of cytomegalovirus (CMV); Sujects with positive extracellular DNA quantification of EB virus (EBV);Subjects tested positive for syphilis;
- Active or latent tuberculosis at screening (can be enrolled if appropriately treated);
- Any of severe laboratory abnormalities in liver function, renal function, bone marrow function, coagulation function, pulmonary function, cardiac function at screening;
- History of severe allergy or known hypersensitivity to any of the active ingredients of the drugs, excipients, or rodent-derived products, xenoproteins included in this trial, or subjects with allergic constitution;
- Severe heart diseases;
- Severe hepatobiliary disease;
- Presence of medical conditions that are obviously unstable or not effectively treated;
- Presence of uncontrollable bacterial, fungal, viral or other infections, requiring antibiotic therapy;
- Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study;
- Have received any commercially available Janus kinase inhibitor or Bruton tyrosine kinase inhibitor within 3 half-lives prior to screening;
- Have received B-cell targeted therapy prior to screening;
- Have received a biologic agent other than B-cell targeted therapy within 5 half-lives prior to screening;
- Previous received therapies with CAR-T cells or other genetically modified T cells;
- Have received therapeutic dose of corticosteroids within 7 days prior to leukapheresis or within 72 hours prior to infusion;
- Have received any other study drugs for SLE within 4 weeks prior to leukapheresis;
- Subjects that have undergone major surgery within 4 weeks prior to lymph depletion or those who are scheduled to undergo major surgery during the study period, or whose surgical wounds have not fully healed prior to enrollment;
- Subjects that have donated blood for ≥ 400mL or had significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received a blood transfusion within 8 weeks, or plan to donate blood during the study period;
- History of ≥ grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy;
- Subjects with severe mental illness;
- Alcoholics or subjects with a history of drug abuse;
- Female subjects who are pregnant or lactating, or intend to pursue pregnancy within 2 years after the cell infusion; male patients whose female sexual partners intend to conceive within 2 years after the cell infusion;
- History of malignancy；
- Patients that have contraindications to any of the study procedures or have other medical conditions that may expose them to unacceptable risk, in the judgment of the investigators and/or clinical criteria.
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06106906
Start Date
June 19 2024
End Date
December 1 2027
Last Update
January 8 2025
Active Locations (1)
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1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022