Drugs / CYNK-001
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04309084 | May 2020 → Jan 2023 | blood coagulation disease, hemorrhagic disease, immunoproliferative disorder, lymphoproliferative syndrome +3 | Celularity Incorporated | Unknown | No outcome recorded |
| Phase 1 | NCT04310592 | Mar 2020 → Jan 2023 | acute myeloid leukemia | Celularity Incorporated | Terminated | No outcome recorded Stop: Business |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05218408 | Sep → Oct 2021 | giant cell glioblastoma | Celularity Incorporated | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04365101 | Sep 2020 → Aug 2021 | COVID-19, acute respiratory distress syndrome, immune system disorder, viral pneumonia | Celularity Incorporated | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-04-08 | Celularity Incorporated | Results Celularity to Present Data Showing Senescent Cell Elimination by Off-the-Shelf Natural Killer Cells Derived from Human Placental Cells celularity.com ↗
The preclinical data, which suggest that Celularity’s placenta-derived unmodified natural killer (NK) cells (CYNK-001) and genetically modified NK cells (CYNK-201) may serve as potent and selective senolytic agents for use in addressing age-related diseases, will be presented on May 9, 2024. |
| 2023-04-27 | Celularity Incorporated | Results Celularity Announces Clinical Data on Human Placental-derived Unmodified Allogeneic Natural Killer Cell Therapy Candidate CYNK-001 in Adult Patients With Relapsed Refractory And Measurable Residual Disease-positive Acute Myeloid Leukemia celularity.com ↗
In patients with relapsed refractory acute myeloid leukemia (R/R AML) treated with a four-dose regimen consisting of 1.8 billion CYNK-001 cells per dose, two of four patients achieved an objective response at Day 28 |
| 2022-09-26 | Celularity Incorporated | Results Celularity Publishes New Data in Frontiers in Immunology Demonstrating Placental-derived Natural Killer Cells (CYNK) Recognized and Eliminated Influenza A Virus (IAV)-infected Cells In Vitro celularity.com ↗
The study demonstrated how IAV sensitizes infected cells for targeting by CYNK-001 via multiple stress ligand and NK receptor activating pathways. |
| 2021-12-27 | Celularity Incorporated | Regulatory Celularity Receives Fast Track Designation from U.S. FDA for its NK Cell Therapy CYNK-001 in Development for the Treatment of AML celularity.com ↗
Celularity Inc. (Nasdaq: CELU) (“Celularity”), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, in development for the treatment of acute myeloid leukemia (AML). |
| 2021-04-13 | Celularity Incorporated | Regulatory Celularity Receives Orphan Drug Designation for Natural Killer Cell Therapy CYNK-001 in the Treatment of Malignant Gliomas celularity.com ↗
the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, for the treatment of patients with malignant gliomas. |
| 2021-03-18 | Celularity Incorporated | Regulatory Celularity Announces Fast Track Designation by the FDA for our Natural Killer Cell Therapy CYNK-001 in the Treatment of Recurrent Glioblastoma Multiforme celularity.com ↗ |
| 2020-12-02 | Celularity Incorporated | Results Celularity Announces Positive DMC Safety Review and Continuation of its Phase I/II CYNK-001-COVID-19 (CYNKCOVID) Study celularity.com ↗
The DMC confirmed the absence of dose-limiting toxicities and recommended to move forward with the trial. |
| 2020-04-02 | Celularity Incorporated | Regulatory Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy celularity.com ↗
Celularity Inc. (“Celularity” or the “Company”), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. |
| 2020-01-22 | Celularity Incorporated | Regulatory Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy celularity.com ↗
Celularity, Inc. (“Celularity” or the “Company”), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application for CYNK-001 in patients with glioblastoma multiforme (GBM). |
| 2019-11-22 | Celularity Incorporated | Results Celularity Presents Pre-Clinical Data Demonstrating the Potential of Allogeneic Placental-Derived, Cryopreserved NK Cell Therapy (CYNK-001) in Glioblastoma at the 2019 Society for Neuro-Oncology Annual Meeting celularity.com ↗
Results from pre-clinical studies demonstrated in vivo anti-GBM activity of CYNK-001. |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CYNK-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04365101 ↗ |
| Modality | Cell therapy | “cell therapy” NCT04309084 ↗ |
| Route | Intravenous | “Participants received intravenous infusions of CYNK-001 on Days 1, 4, and 7.” NCT04365101 ↗ |