NCT03624686

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
OTHER	peripheral blood	draw peripheral blood

Timeline

• Start date: 2018-03-09
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-08-10
• Last updated: 2018-08-10

Locations

1 site across 1 country: Taiwan