Production of Clinical-grade Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory B-cell Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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Production of Clinical-grade Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory B-cell Malignancies

Conditions
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Leukemia

Intervention / Treatment
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* Other: peripheral blood


Participation Criteria
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Eligibility Criteria
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At least 14 years of age (underage patients under the age of 20 only collect peripheral venous blood, do not perform double-lumen venous catheter and white blood cell separation). There are no known serious systems or diseases with systemic immunodeficiency, but blood-related cancers are not. Systemic chemotherapy and target treatment were not received within 14 days. The subject consent form has been signed prior to the program-related procedures.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy volunteer<br> | Other: peripheral blood<br>* draw peripheral blood<br>|
| luekemia patient<br> | Other: peripheral blood<br>* draw peripheral blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia,Immunotherapy,chimeric antigen receptor,non-Hodgkin's lymphoma