Drugs / FT516
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04630769 | Apr 2021 → Jan 2022 | fallopian tube adenocarcinoma, ovarian cancer, primary peritoneal carcinoma | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase 1 | NCT04551885 | Sep 2020 → Aug 2023 | cancer | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT04363346 | May 2020 → Feb 2021 | COVID-19 | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase 1 | NCT04023071 | Oct 2019 → Oct 2023 | B-cell neoplasm, acute myeloid leukemia | Fate Therapeutics | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2021-12-13 | Fate Therapeutics | Results Fate Therapeutics Highlights Positive Durability of Response Data from FT516 Phase 1 Study for B-cell Lymphoma and Announces FDA Regenerative Medicine Advanced Therapy Designation Granted to FT516 for Relapsed / Refractory DLBCL fatetherapeutics.com ↗
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today presented positive clinical data from the dose-escalation stage of its ongoing Phase 1 study of FT516 for patients with relapsed / refractory B-cell lymphoma (BCL) at the 63 rd American Society of Hematology Annual Meeting and Exposition. |
| 2021-08-19 | Fate Therapeutics | Results Fate Therapeutics Announces Positive Interim Clinical Data from its FT596 and FT516 Off-the-shelf, iPSC-derived NK Cell Programs for B-cell Lymphoma fatetherapeutics.com ↗
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today highlighted positive interim clinical data from the Company’s FT516 and FT596 programs for patients with relapsed / refractory B-cell lymphoma. |
| 2021-06-04 | Fate Therapeutics | Results Fate Therapeutics Highlights Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma at 2021 ASCO Annual Meeting fatetherapeutics.com ↗
8 of 11 Patients in Dose Escalation Cohorts 2 and 3 Achieved Objective Response |
| 2021-05-13 | Fate Therapeutics | Results Fate Therapeutics Announces Encouraging Interim Phase 1 Data for iPSC-derived NK Cell Programs in Relapsed / Refractory Acute Myeloid Leukemia fatetherapeutics.com ↗
4 of 9 Patients in FT516 Monotherapy Study Achieved Objective Response with Complete Leukemic Blast Clearance in the Bone Marrow |
| 2020-12-04 | Fate Therapeutics | Results Fate Therapeutics Reports Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma fatetherapeutics.com ↗
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced positive interim data from the Company’s dose escalation Phase 1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. |
| 2020-01-13 | Fate Therapeutics | Regulatory Fate Therapeutics Announces Expansion of FT516 Clinical Investigation and Publication of Preclinical Data in the Journal Blood fatetherapeutics.com ↗ |
| 2019-12-07 | Fate Therapeutics | Results Fate Therapeutics Announces Clinical Data from Landmark Phase 1 Studies of First-ever Universal, Off-the-shelf, iPSC-derived NK Cell Cancer Immunotherapy Programs fatetherapeutics.com ↗
A bone marrow biopsy obtained at Day 42 following the completion of the first FT516 treatment cycle showed no morphologic evidence of leukemia and evidence of hematopoietic recovery. |
| 2019-02-06 | Fate Therapeutics | Regulatory Fate Therapeutics Announces FDA Clearance of IND Application for World’s First Cell Therapy Derived from an Engineered Pluripotent Stem Cell fatetherapeutics.com ↗
FT516 is the first-ever cell therapy derived from a genetically engineered pluripotent stem cell cleared for clinical testing in the world, and is the Company’s second off-the-shelf, iPSC-derived NK cell product candidate cleared for clinical investigation by the FDA within the past two months. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FT516 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04023071 ↗ |
| Modality | Cell therapy | “FT516 is an induced pluripotent stem cell (iPSC)-derived natural killer-cell therapy” PMID 40610174 ↗ Jul 2025 |
| Route | Intravenous | “FT516 was administered intravenously at escalating doses” PMID 40610174 ↗ Jul 2025 |