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Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

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ClinicalTrials.gov Identifier: NCT02822495
Expanded Access Status : Available
First Posted : July 4, 2016
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Atara Biotherapeutics

Tracking Information
First Submitted Date June 30, 2016
First Posted Date July 4, 2016
Last Update Posted Date September 30, 2020
 
Descriptive Information
Brief Title Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
Brief Summary The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
Detailed Description Participants for whom there are no other appropriate therapeutic options and who are not eligible to enroll in other tabelecleucel clinical studies, may be enrolled in this study. After the screening period, participants will receive intravenous infusions of tabelecleucel (1.6 to 2 × 10^6cells/kg) on Day 1, Day 8, and Day 15 of every 35-day cycle. Clinical assessment of disease response is recommended approximately 15 days after the last dose of tabelecleucel to assess the need for additional treatment. The end of expanded access protocol (EAP) visit should be performed at 30 days after the last dose of tabelecleucel.
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Biological: tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Other Names:
  • tab-cel®
  • ATA129
  • EBV-CTL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Willis Navarro, MD 650-278-8930 ext 1 clinicalstudies@atarabio.com
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT02822495
Responsible Party Atara Biotherapeutics
Study Sponsor Atara Biotherapeutics
Collaborators Not Provided
Investigators
Study Director: Willis Navarro, MD Atara Biotherapeutics
PRS Account Atara Biotherapeutics
Verification Date September 2020