Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EBV-specific T cells · 1 trial · 3 indications
The ORR is defined as percentage of participants with best overall response of complete remission/response (CR) or partial remission/response (PR) based on investigator's assessment. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and PR is a 50 % or greater reduction in the size of all lymphomatous lesions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is clearance of EBV without subsequent development of EBV+ LPD; and PR is at least a 10-fold decrease in EBV DNA levels.
| Arm | Type | Description |
|---|---|---|
| HCT EBV+ PTLD R/R Rituximab | EXPERIMENTAL | Patients with Epstein-Barr virus positive (EBV+) posttransplant lymphoproliferative disorders (PTLD) hematopoietic cell transplant (HCT) who were relapse/refractory (R/R) to rituximab will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| SOT EBV+ PTLD R/R Rituximab | EXPERIMENTAL | Patients with EBV+PTLD solid organ transplant (SOT) who were R/R to rituximab or R/R to rituximab and chemotherapy will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| EBV+ AID-LPD | EXPERIMENTAL | Patients with EBV+ acquired immunodeficiency (AID) lymphoproliferative disorder (LPD) will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity |
| EBV+ PID-LPD | EXPERIMENTAL | Patients with EBV+ primary immunodeficiency (PID) LPD will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| EBV+ Viremia | EXPERIMENTAL | Patients with EBV+ viremia will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| EBV+ Leiomyosarcoma | EXPERIMENTAL | Patients with EBV+ leiomyosarcoma (LMS) will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| EBV+ Lymphoma | EXPERIMENTAL | Patients with EBV+ lymphoma will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| EBV+ NPC | EXPERIMENTAL | Patients with EBV+ nasopharyngeal carcinoma (NPC) will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| EBV+ Other Solid Tumor | EXPERIMENTAL | Patients with EBV+ other solid tumors will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| EBV-specific T cells (EBV-CTLs) | BIOLOGICAL | EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders. |
Inclusion Criteria: * Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma or other EBV-associated malignancy. OR * Evaluable disease as demonstrated by clinical and/or radiologic studies with current or prior elevated blood levels of EBV DNA exceeding 500 copies/m...
EBV-specific T cells is an investigational cell therapy being studied for the treatment of EBV-induced Lymphomas and other EBV-associated malignancies. It is also being evaluated in transplant patients with EBV viremia who are at high risk for developing a recurrent EBV lymphoma.
EBV-specific T cells is being developed by Atara Biotherapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ATRA.
EBV-specific T cells is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. One Phase 2 clinical trial for this therapy has been completed.
EBV-specific T cells has been studied in one completed Phase 2 clinical trial with the identifier NCT01498484. This trial enrolled 87 participants and evaluated the therapeutic effects of Epstein-Barr Virus immune T-lymphocytes derived from a normal HLA-compatible or partially-matched third-party donor.
EBV-specific T cells is classified as a monoclonal antibody modality, though it is described as an immune T-lymphocyte therapy. The therapy is derived from donor cells and is being investigated for its effects on EBV-related conditions, including lymphomas and malignancies.