A Phase I Dose Escalation Trial Using In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-cell Malignancies
Phase of Trial: Phase I
Latest Information Update: 03 Jan 2017
At a glance
- Drugs Epstein-Barr virus-specific T-cell therapy Atara/MSKCC (Primary)
- Indications Acute lymphoblastic leukaemia
- Focus Adverse reactions
- 07 Jun 2017 Biomarkers information updated
- 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).
- 07 Jul 2016 Planned End Date changed from 1 Sep 2016 to 1 Sep 2017.