Drugs / ATA230
ATA230
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00078533 | Apr 2004 → Jul 2010 | cytomegalovirus infection | Baylor College of Medicine | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03010332 | — | cytomegalovirus infection | Atara Biotherapeutics | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2017-12-11 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces Updated Positive Interim Results from Multicenter Expanded Access Study of tabelecleucel in Patients with Rituximab-Refractory Epstein-Barr Virus (EBV) Associated Post-Transplant Lymphoproliferative Disorder (PTLD) atarabio.com ↗
The reported response rate of 64% in all patients was similar in those with CMV viremia and disease. |
| 2017-10-26 | Atara Biotherapeutics | Regulatory Atara Biotherapeutics Receives Rare Pediatric Disease Designation from FDA for ATA230 for Treatment of Congenital Cytomegalovirus (CMV) Infection atarabio.com ↗
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune diseases and serious viral infections, today announced that ATA230 was granted Rare Pediatric Disease Designation for the treatment of congenital cytomegalovirus (CMV) infection by the U.S. Food and Drug Administration (FDA). |
| 2017-09-05 | Atara Biotherapeutics | Regulatory Atara Biotherapeutics Receives FDA Orphan Drug Designation for ATA230 atarabio.com ↗
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading "off-the-shelf" T-cell immunotherapy company developing novel treatments for patients with cancer and autoimmune diseases, today announced that ATA230 was granted orphan drug designation for the treatment of cytomegalovirus (CMV) viremia and disease in immunocompromised patients by the U.S. Food and Drug Administration (FDA). |
| 2016-10-11 | Atara Biotherapeutics | Regulatory Atara Bio Receives Positive Opinion from EMA on Orphan Drug Designation for Allogeneic Cytomegalovirus (CMV)-specific Cytotoxic T Lymphocytes (CTL) for Treatment of CMV Infection in Patients with Impaired Immune Systems atarabio.com ↗ |
All press releases naming this drug 4 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ATA230 | “ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens.” NCT03010332 ↗1“ATA230” NCT03010332 ↗ |
| Known as | CMV CTL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00078533 ↗ |
| Known as | CMV-CTLs | “ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens.” NCT03010332 ↗ |
| Known as | CMV-specific cytotoxic T-lymphocytes | “These cells are called CMV-specific cytotoxic T-lymphocytes or CMV CTL, and they will be given to the patient around 30 days after their transplant.” NCT00078533 ↗ |
| Action | Deplete | “This stimulation will train the T cells to kill cells with the pp65 from the CMV virus on their surface.” NCT00078533 ↗ |
| Modality | Cell therapy | “ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes” NCT03010332 ↗ |
| Route | Intravenous | “The donor's CMV CTL cells will be thawed and injected into the patients intravenous line for a period of 10 minutes” NCT00078533 ↗ |