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Immunotherapy is a promising therapeutic approach for patients with cancers. Patients with acute lymphoblastic leukemia (ALL) experiencing early relapse less than 18 months from diagnosis had very poor prognosis with 5-year survival rate of 21% (1). Recent clinical trials demonstrated that infusions of autologous T cell modified with chimeric antigen receptors (CARs) induced durable complete remissions in patients with relapse or refractory B-cell ALL (2-4). The editors of Science Journal announced cancer immunotherapy as the breakthrough of the year for 2013 (5). On Jan 30, 2015, Dr. Steven M. Altschuler, chief executive officer of the Children's Hospital of Philadelphia and 9-year-old ALL patient Emily Whitehead with 3-year leukemia free after CAR-T cell infusion were invited to White House for President Barack Obama's announcement of the Precision Medicine Initiative. The MIT Technology Review announced that the top one breakthrough technology in 2016 is genetically engineered immune cells saving the lives of cancer patients. This project will focus on the manufacturing of clinical-grade anti-CD19 CARs for B-cell malignancies in the future clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy volunteer |
| ||
| luekemia patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peripheral blood | Other | draw peripheral blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical process of CAR-T cells | Establish a clinical process for CAR-T cells in the GTP laboratory and document these steps to establish a complete standard operation procedure (SOP) and further validate the process to comply with GMP regulations | JAN/2018-DEC/2020 |
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Leukemia patients and healthy volunteer aged 14 and over
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Hsiang Chang, MDPHD | Contact | 0905907528 | 702084@ntuh.gov.tw | |
| Jhen Ling Wang, bachelor | Contact | 0966768773 | 1063960@NTUH.GOV.TW |
| Name | Affiliation | Role |
|---|---|---|
| Yu-Hsiang Chang, MDPHD | natinal taiwan university hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |