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Research Report
Chimeric Antigen Receptor T-Cell Therapy Targeting CD19 (CART-19): A Comprehensive Report
1. Introduction to CART-19 Therapy
Defining CART-19: A Revolutionary Cellular Immunotherapy
Chimeric Antigen Receptor T-cell (CART) therapy targeting the CD19 protein (CART-19) represents a transformative class of adoptive cell transfer immunotherapy. This innovative approach involves the genetic modification of a patient's own T-lymphocytes (autologous T-cells) to recognize and eliminate cancer cells that express the CD19 antigen on their surface.[1] This therapy has emerged as a powerful and potentially curative option, particularly for patients with various B-cell hematological malignancies that are relapsed or refractory (r/r) to conventional treatments.[1] The personalized nature of CART-19 therapy, where T-cells are harvested from the patient, engineered ex vivo, expanded to therapeutic doses, and then re-infused, distinguishes it fundamentally from traditional pharmaceutical agents like small molecules or monoclonal antibodies.[1] The unprecedented efficacy observed in clinical trials has led to the approval of several CART-19 products by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).[3]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2023/10/26 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
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