Product Description
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT04554914)
Mechanisms of Action: Cell Therapy
Novel Mechanism: No
Modality: Cell Therapy
Route of Administration: Intravenous
FDA Designation: Priority Review - Epstein-Barr Virus Infections *
Approval Status: Not Approved
Approved Countries: Belgium | Croatia | Czech | European Medicines Agency | Finland | Germany | Greece | Iceland | Ireland | Italy | Lithuania | Poland | Portugal | Slovakia | Sweden
Approved Indications: None
Company: Allogene Therapeutics
Company Location: Western America
Company Founding Year: 2017
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, France, Italy, Spain, United Kingdom, United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
- PDUFA date for Tab-cel is January 10, 2026, with potential $40 million milestone payment upon FDA approval.
- Tab-cel's BLA accepted with PDUFA target action date of January 15, 2025 for potential approval in EBV+ PTLD treatment.
- Clinical Outcomes Reported - Atara Biotherapeutics presented P3 Epstein-Barr Virus Infections|Stem Cell Transplant|Transplantation Unspecified|Autoimmune Disease Unspecified results on 2024-01-31 for Tabelecleucel
Highest Development Phases
Phase 3: Allogeneic Stem Cell Transplant|Epstein-Barr Virus Infections|Hematopoietic Stem Cell Transplant|Lymphoproliferative Disorders|Transplantation Unspecified
Phase 2: Acquired Immunodeficiency Syndrome|Deficiency Diseases|Leiomyosarcoma|Smooth Muscle Tumor
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04554914 |
EBVision | P2 |
Active, not recruiting |
Transplantation Unspecified|Leiomyosarcoma|Allogeneic Stem Cell Transplant|Lymphoproliferative Disorders|Epstein-Barr Virus Infections|Hematopoietic Stem Cell Transplant|Deficiency Diseases|Acquired Immunodeficiency Syndrome |
2027-06-01 |
55% |
2026-04-28 |
Primary Endpoints|Treatments|Trial Status |
2024-516623-14-00 |
ATA129-EBV-205 | P2 |
Recruiting |
Smooth Muscle Tumor|Leiomyosarcoma |
2026-07-31 |
55% |
2025-05-02 |
Treatments |
NCT03394365 |
ALLELE | P3 |
Recruiting |
Lymphoproliferative Disorders|Transplantation Unspecified|Epstein-Barr Virus Infections|Hematopoietic Stem Cell Transplant|Allogeneic Stem Cell Transplant |
2030-05-31 |
8% |
2025-11-01 |
Patient Enrollment|Primary Endpoints|Treatments |
2024-516622-57-00 |
ATA129-EBV-302 | P3 |
Recruiting |
Transplantation Unspecified |
2027-06-15 |
8% |
2025-05-02 |
Treatments |