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

NCT03624686 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2018-08-10

No results posted yet for this study

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

Interventions

OTHER

peripheral blood

draw peripheral blood

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Yu-Hsiang Chang, MDPHD · natinal taiwan university hospital

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624686 on ClinicalTrials.gov