Date: 2016-12-12
Type of information: Submission of a clinical trial application
phase: 3
Announcement: submission of a clinical trial application
Company: Atara Biotherapeutics (USA - CA)
Product: ATA 129 (EBV-CTL)
Action
mechanism: cell therapy/immunotherapy product. Atara's EBV-CTL utilizes a technology in which T-cells are collected from the blood of third-party donors and then exposed to EBV antigens. The resulting activated T-cells are then expanded, characterized, and stored for future therapeutic use in an appropriate partially human leukocyte antigen, or HLA, matched patient, providing an "off-the-shelf", allogeneic, cellular therapeutic option for patients. In the context of EBV-PTLD, Atara's EBV-CTL finds the cancer cells expressing EBV and kills them. EBV-CTL is currently being studied in ongoing Phase 2 clinical trials.
Disease: rituximab-refractory EBV-Associated Post Transplant Lymphoproliferative Disorder (EBV-PTLD)
Therapeutic area: Infectious diseases - Transplantation
Country:
Trial details:
Latest
news: * On December 12, 2016, Atara Biotherapeutics announced that it has reached agreement with the FDA on the designs of two Phase 3 trials for ATA 129 intended to support approval in the treatment of rituximab-refractory EBV-Associated Post Transplant Lymphoproliferative Disorder (EBV-PTLD) after hematopoietic cell transplant (HCT) or solid organ transplant (SOT). These two Phase 3 trials will support potential approvals in two separate indications.
MATCH Trial (EBV-PTLD after HCT) : This multicenter, open label, single arm study is designed to enroll approximately 35 patients previously treated with rituximab.
ALLELE Trial (EBV-PTLD after SOT): This multicenter, open label study includes two non-comparative cohorts
Each cohort is designed to enroll approximately 35 patients. The first cohort includes patients who previously received rituximab monotherapy. The second cohort includes patients who previously received rituximab plus chemotherapy. Both cohorts will enroll concurrently
The primary endpoint of both the MATCH and ALLELE trials is objective response rate, defined as the percent of patients achieving either a complete or partial response to treatment with ATA 129. Secondary endpoints for both trials include duration of response, overall survival, safety, quality of life metrics, and other data in support of potential health economic benefits. The trials are expected to open initially in the U.S. and later expand to include ex-U.S. sites.
Atara has manufactured ATA 129 lots intended for use in the Phase 3 trials, and Atara is continuing to generate and review data comparing this new material with that previously produced by Memorial Sloan Kettering (MSK). Atara's review of the comparability data generated to date suggests that additional analysis is required. As a result, Atara intends to conduct these analyses and meet with FDA in early 2017 to review these data and gain alignment prior to initiating the Phase 3 trials.
