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

NCT03624686 | Unknown

• 1 other identifier: 201711021RIND
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute Lymphoblastic Leukemia,Immunotherapy,chimeric antigen receptor,non-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

healthy volunteer

Other: peripheral blood

luekemia patient

Other: peripheral blood

Interventions

peripheral blood OTHER

draw peripheral blood

healthy volunteer; luekemia patient

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Leukemia patients and healthy volunteer aged 14 and over

1. 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). 2. There are no known serious systems or diseases with systemic immunodeficiency, but blood-related cancers are not. 3. Systemic chemotherapy and target treatment were not received within 14 days. 4. The subject consent form has been signed prior to the program-related procedures.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yu-Hsiang Chang, MDPHD

  natinal taiwan university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Hsiang Chang, MDPHD

CONTACT

0905907528; 702084@ntuh.gov.tw

Jhen Ling Wang, bachelor

CONTACT

0966768773; 1063960@NTUH.GOV.TW

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: March 9, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 10, 2018

Record last verified: 2018-03

Locations

TW (1)