Drugs / NTLA-5001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05066165 | Dec 2021 → Jul 2022 | acute myeloid leukemia | Intellia Therapeutics | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-03-09 | Intellia Therapeutics | Regulatory Intellia Therapeutics Receives U.S. FDA Orphan Drug Designation for NTLA-5001 for the Treatment of Acute Myeloid Leukemia intelliatx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia’s ex vivo investigational T cell receptor (TCR)-T cell therapy, NTLA-5001, for the treatment of acute myeloid leukemia (AML). |
| 2021-09-16 | Intellia Therapeutics | Regulatory Intellia Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug Application for NTLA-5001, its CRISPR/Cas9-Engineered TCR-T Cell Candidate for Acute Myeloid Leukemia intelliatx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application for NTLA-5001, the company’s first wholly-owned ex vivo CRISPR genome editing candidate for the treatment of cancer. |
| 2020-12-05 | Intellia Therapeutics | Results Intellia Therapeutics Presents New Preclinical Data Supporting Its CRISPR/Cas9-Engineered TCR-T Cell Treatment for Acute Myeloid Leukemia at the 62nd ASH Annual Meeting intelliatx.com ↗
Specifically, NTLA-5001’s lead TCR-T cells resulted in significantly higher anti-tumor activity in mouse models of acute leukemias than that observed in mice treated with cells engineered using the standard process. |
| 2020-05-12 | Intellia Therapeutics | Results Intellia Therapeutics Reports Progress on CRISPR/Cas9 AML Cancer Therapy Using Proprietary Cell Engineering Process at the 23rd Annual Meeting of the American Society of Gene and Cell Therapy intelliatx.com ↗
Intellia researchers are presenting new data in support of NTLA-5001, the company’s engineered cell therapy candidate for the treatment of acute myeloid leukemia (AML). |
| 2020-02-10 | Intellia Therapeutics | Results Intellia Therapeutics Presents New Data From Its Engineered Cell Therapy and In Vivo Programs at Keystone Symposia’s Engineering the Genome Conference intelliatx.com ↗
We are observing very favorable preclinical data with our engineered T cells, and we are moving ahead with IND-enabling studies and manufacturing for NTLA-5001, to enable a regulatory submission in the first half of 2021. |
All press releases naming this drug 6 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NTLA-5001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05066165 ↗ |
| Modality | Cell therapy | “Autologous WT1-directed TCR T cells” NCT05066165 ↗ |
| Route | Intravenous | “as intravenous infusion” NCT05066165 ↗ |
| Target | WT1 | “Autologous WT1-directed TCR T cells” NCT05066165 ↗ |