Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349343
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-25
Brief Title:
CD19BCMA HLA-independent TCR-T Cell Therapy for RefractoryModerate-to-severe Systemic Lupus Erythematosus
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Clinical Study of the Safety and Efficacy of CD19BCMA HLA-independent TCR-T Cell Therapy for RefractoryModerate-to-severe Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 CD19B cell maturation antigen BCMA human leukocyte antigen HLA-independent T cell receptor TCR -T therapy in refractorymoderate-to-severe systemic lupus erythematosusSLE
Detailed Description:
The prognosis of patients with refractorymoderate-to-severe systemic lupus erythematosus SLE remains poor due to two major therapeutic obstacles 1 current treatment strategies including glucocorticoids immunosuppressive agents biological agents are still difficult to achieve disease control making the disease condition of some patients continue to be active or even worse 2 some patients are unable to wean themselves off glucocorticoid and face the risk of numerous adverse effects caused by long-term glucocorticoid dependence such as glucocorticoid-related diabetes femoral head necrosis hypertension stress ulcers and infection etc Therefore there is a strong unmet clinical need for more effective treatment for patients suffering from refractorymoderate-to-severe SLE Several preclinical and clinical studies have shown the efficacy of chimeric antigen receptor T CAR-T cell therapy in SLE Compared with traditional CAR-T cell therapy human leukocyte antigen HLA-independent T cell receptor TCR cell therapy can induce a controllable immune response and maintain a better response durability due to the mechanism of activation and regulation of the natural T cell antigen receptor while releasing a lower level of cytokines which can effectively minimizes toxicities The aim of this study is to investigate the safety tolerability preliminary efficacy pharmacokinetics PK and pharmacodynamics PD of cluster of differentiation 19 CD19B cell maturation antigen BCMA HLA-independent TCR-T cell therapy in refractorymoderate-to-severe SLE Patients with refractorymoderate-to-severe SLE will be invited to participate in the study to receive CD19BCMA HLA-independent TCR-T cell intravenous infusion and follow-up visits of up to 1 years after enrollment Given that the pretreatment chemotherapy fludarabinecyclophosphamide of CAR-T therapy in current SLE clinical studies is mostly based on experiences in hematologic malignancies which may cause severe complications such as infection there is a lack of evidence-based rationale for patients with SLE to receive pretreatment chemotherapy This study will explore the feasibility of TCR-T cell therapy without pretreatment chemotherapy in the treatment of refractorymoderate-to-severe systemic lupus erythematosus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None