Drugs / inaleucel
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04632316 | Dec 2020 → Apr 2023 | acute myeloid leukemia | Glycostem Therapeutics BV | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2023-04-20 | Glycostem Therapeutics BV | Regulatory Inaleucel Added to WHO Recommended List as INN for oNKord® glycostem.com ↗ |
| 2022-05-13 | Glycostem Therapeutics BV | Results Glycostem announces new data presentation at EHA 2022 Congress highlighting early safety and clinical course of oNKord® in patients with Acute Myeloid Leukemia glycostem.com ↗
Our initial clinical data shows that all patients in the first dose cohort reached some level of MRD negativity with an excellent safety profile thus far. |
| 2021-11-04 | Glycostem Therapeutics BV | Results Glycostem announces initial clinical data to be presented at 2021 ASH Annual Meeting glycostem.com ↗
Clearance of measurable residual disease seen in one patient for 6 months and in the second patient for 1 month after a single infusion of oNKord®, an off-the-shelf NK cell immunotherapy, in the lowest dose cohort |
| 2020-10-12 | Glycostem Therapeutics BV | Regulatory FDA grants Glycostem’s oNKord® Orphan Drug Designation for Multiple Myeloma glycostem.com ↗
Glycostem announces it has received the FDA’s Orphan Drug Designation (ODD) for treatment of Multiple Myeloma (MM) patients with its investigational product oNKord®. |
| 2019-06-25 | Glycostem Therapeutics BV | Regulatory Glycostem received GMP license for oNKord® glycostem.com ↗
25th June 2019 - Glycostem Therapeutics BV today announced they have received GMP license for Glycostem’s proprietary closed production system used to manufacture their lead product, oNKord®, an off-the-shelf,allogeneic Natural Killer(NK) cell therapy. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | inaleucel | “oNKord®/inaleucel allogeneic off-the-shelf NK cell product from Glycostem Therapeutics” PMID 38304826 ↗ Jan 2024 |
| Known as | oNKord | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04632316 ↗ |
| Modality | Cell therapy | — CHEMBL5314683 ↗ |