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

NCT ID: NCT03624686

Last Updated: 2018-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-09

Study Completion Date

2020-12-31

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.

Detailed Description

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Conditions

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Leukemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy volunteer

peripheral blood

Intervention Type OTHER

draw peripheral blood

luekemia patient

peripheral blood

Intervention Type OTHER

draw peripheral blood

Interventions

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peripheral blood

draw peripheral blood

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Hsiang Chang, MDPHD

Role: PRINCIPAL_INVESTIGATOR

natinal taiwan university hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Hsiang Chang, MDPHD

Role: CONTACT

0905907528

Jhen Ling Wang, bachelor

Role: CONTACT

0966768773

Facility Contacts

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Yu-Hsiang Chang, MDPHD

Role: primary

0905907528

Other Identifiers

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201711021RIND

Identifier Type: -

Identifier Source: org_study_id

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