Drugs / ProTmune
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT02743351 | Dec 2016 → Dec 2020 | acute graft versus host disease, acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia +1 | Fate Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2021-05-05 | Fate Therapeutics | Results Fate Therapeutics Reports First Quarter 2021 Financial Results and Highlights Operational Progress fatetherapeutics.com ↗
While we are disappointed that the PROTECT study of ProTmune did not meet its primary endpoint for prevention of acute graft-versus-host disease following allogeneic stem cell transplant |
| 2018-05-10 | Fate Therapeutics | Results Fate Therapeutics Reports First Quarter 2018 Financial Results and Highlights Operational Progress fatetherapeutics.com ↗
Additionally, no events of cancer relapse have been reported in our Phase 1 PROTECT study of ProTmune, and new immune reconstitution data from these subjects support the potential of ProTmune to fight against infections and residual disease. |
| 2018-03-19 | Fate Therapeutics | Results Fate Therapeutics Announces Additional Clinical Data from Phase 1 Stage of PROTECT Clinical Trial of ProTmune™ 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, announced today additional clinical data from the Phase 1 stage of its PROTECT clinical trial of ProTmune™, the Company’s next-generation hematopoietic cell graft. |
| 2017-12-11 | Fate Therapeutics | Results Fate Therapeutics Announces Day 100 Clinical Results from Phase 1 Stage of PROTECT Trial of ProTmune™ and Initiation of Phase 2 Stage fatetherapeutics.com ↗
All seven subjects receiving ProTmune remained alive and relapse-free during the first 100 days following hematopoietic cell transplantation (HCT). |
| 2016-11-07 | Fate Therapeutics | Regulatory Fate Therapeutics Reports Third Quarter 2016 Financial Results fatetherapeutics.com ↗
ProTmune has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation by the European Medicines Agency. |
| 2016-09-26 | Fate Therapeutics | Regulatory Fate Therapeutics Receives FDA Orphan Drug Designation for ProTmune™ in Allogeneic Hematopoietic Cell Transplantation fatetherapeutics.com ↗ |
| 2016-06-20 | Fate Therapeutics | Regulatory Fate Therapeutics Announces FDA Fast Track Designation for ProTmune™ fatetherapeutics.com ↗ |
| 2016-02-21 | Fate Therapeutics | Results Fate Therapeutics to Present Preclinical Data for ProTmune™ at 2016 BMT Tandem Meetings fatetherapeutics.com ↗
These encouraging new preclinical data, which demonstrate that the cancer-fighting properties of ex vivo programmed donor T cells are maintained following adoptive transfer, continue to underscore the multi-dimensional therapeutic value proposition that we aim to deliver to HCT patients with ProTmune. |
| 2016-01-26 | Fate Therapeutics | Regulatory Fate Therapeutics Announces FDA Clearance of Investigational New Drug Application for ProTmune for Prevention of Acute GvHD and CMV Infection fatetherapeutics.com ↗
The IND is now active and Fate Therapeutics plans to initiate a multi-center, randomized, controlled Phase 1/2 clinical trial in adult patients with hematologic malignancies undergoing mobilized peripheral blood (mPB) hematopoietic cell transplantation (HCT) in mid-2016. |
| 2015-11-05 | Fate Therapeutics | Results Fate Therapeutics to Present Preclinical Data for ProTmune(TM) at ASH 2015 Annual Meeting fatetherapeutics.com ↗
New preclinical data to be presented show that a single administration of programmed cells result in a statistically-significant reduction in GvHD sco |
All press releases naming this drug 12 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 | ProTmune | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02743351 ↗ |
| Modality | Cell therapy | “ProTmune (ex vivo programmed mobilized peripheral blood cells)” NCT02743351 ↗ |