Drugs / TAC01-CD19
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03880279 | May 2020 → Apr 2022 | B-cell non-Hodgkin lymphoma | Triumvira Immunologics, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-11-07 | Triumvira Immunologics, Inc. | Regulatory Triumvira Immunologics Announces Fast Track Designation for Its First TAC T-Cell Therapeutic Product Candidate: TAC01-CD19 triumvira.com ↗
Triumvira Immunologics Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for its novel T-cell therapy product TAC01-CD19 in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after at least 2 prior systemic therapies. |
| 2019-06-18 | Triumvira Immunologics, Inc. | Regulatory Triumvira Immunologics Announces Clearance of IND and CTA by U.S. FDA and Health Canada for Its First TAC T-cell Therapeutic Product Candidate, TAC01-CD19 triumvira.com ↗
Triumvira Immunologics, Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, today announced that both the U.S. Food & Drug Administration (FDA) and Health Canada have cleared Triumvira’s Investigational New Drug (IND) and Clinical Trial Applications (CTA) for its novel T cell therapy product TAC01-CD19 in patients with CD19-postive B-cell malignancies. |
| 2019-05-01 | Triumvira Immunologics, Inc. | Regulatory Triumvira Submits Investigational New Drug (IND) Application to the FDA and Clinical Trial Application (CTA) to Health Canada to Evaluate TAC01-CD19, a T Cell Antigen Coupler Therapy, in Ph 1/2 TACTIC-19 Trial triumvira.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-11-07 | Triumvira Immunologics, Inc. | Triumvira Immunologics Announces Fast Track Designation for Its First TAC T-Cell Therapeutic Product Candidate: TAC01-CD19 triumvira.com ↗ |
| 2019-06-18 | Triumvira Immunologics, Inc. | Triumvira Immunologics Announces Clearance of IND and CTA by U.S. FDA and Health Canada for Its First TAC T-cell Therapeutic Product Candidate, TAC01-CD19 triumvira.com ↗ |
| 2019-05-01 | Triumvira Immunologics, Inc. | Triumvira Submits Investigational New Drug (IND) Application to the FDA and Clinical Trial Application (CTA) to Health Canada to Evaluate TAC01-CD19, a T Cell Antigen Coupler Therapy, in Ph 1/2 TACTIC-19 Trial triumvira.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TAC01-CD19 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03880279 ↗ |
| Modality | Cell therapy | “Autologous TAC (T cell antigen coupler) T cells” NCT03880279 ↗ |
| Target | CD19 | “TAC T Cells Targeting CD19” NCT03880279 ↗ |