Drugs / KITE-585
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | plasma cell myeloma | 2017-08-08 | “submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1, first-in-human trial of KITE-585” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03318861 | Oct 2017 → Dec 2018 | refractory plasma cell neoplasm | Kite, A Gilead Company | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2017-08-08 | Gilead Sciences | Regulatory Kite Submits Investigational New Drug (IND) Application for KITE-585, Anti-BCMA CAR-T Therapy Candidate for Multiple Myeloma gilead.com ↗ |
| 2017-04-04 | Gilead Sciences | Results Kite Presents Promising Preclinical Data from KITE-585, a Fully Human Anti-BCMA CAR T-Cell Product Candidate at the 2017 American Association of Cancer Research (AACR) Annual Meeting gilead.com ↗
In today's oral presentation (Abstract #4979), "Development of KITE-585: A fully human anti-BCMA CAR T-cell therapy for the treatment of multiple myeloma," KITE-585 demonstrated potent in vitro and in vivo activity against MM cell lines. |
All press releases naming this drug 2 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KITE-585 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03318861 ↗ |
| Modality | Cell therapy | “autologous engineered chimeric antigen receptor (CAR) T-cell product” NCT03318861 ↗ |