An Evaluation of the Toxicity and Therapeutic Effects of Epstein-Barr Virus-Immune T-Lymphocytes Derived From a Normal HLA-Compatible or Haplotype-Matched Donor in the Treatment of EBV-Associated Lymphoproliferative Diseases or Malignancies and Patients With Detectable Circulating Levels of EBV DNA Who Are at High Risk for EBV-Associated Lymphoproliferative Diseases
Phase of Trial: Phase I/II
Latest Information Update: 06 Apr 2017
At a glance
- Drugs Epstein-Barr virus-specific T-cell therapy Atara/MSKCC (Primary)
- Indications Cancer; Lymphoma; Lymphoproliferative disorders
- Focus Therapeutic Use
- Sponsors Atara Biotherapeutics
- 31 Mar 2017 Planned End Date changed from 1 Dec 2017 to 1 Jan 2018.
- 31 Mar 2017 Planned primary completion date changed from 1 Mar 2017 to 1 Jan 2018.
- 03 Jan 2017 According to an Atara Biotherapeutics media release, the Company plans to submit in 2018 an application for Conditional Marketing Authorization Approval of ATA 129 in the treatment of patients with rituximab refractory EBV-PTLD following hematopoietic cell transplant (HCT). The Conditional MAA will be based on data from phase I and II studies and supported by available data from the pase III studies in rituximab refractory EBV-PTLD after HCT and solid organ transplantation (SOT).