Drugs / Flotetuzumab

Trials 8

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT05506956 Oct 2022 → Jun 2024 acute myeloid leukemia Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 1 NCT04681105 Nov 2020 → Aug 2025 B-cell acute lymphoblastic leukemia, CD4+/CD56+ hematodermic neoplasm, Hodgkins lymphoma, T-cell acute lymphoblastic leukemia +4 City of Hope Medical Center Completed No outcome recorded
Phase 1 NCT04158739 Jan 2020 → Sep 2022 overdue acute myeloid leukemia Children's Oncology Group Active not recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02152956 Jun 2014 → Jul 2022 acute myeloid leukemia MacroGenics Terminated No outcome recorded Stop: Business
Phase 23 trials
Phase 2 NCT05063123 Jan 2022 → Aug 2024 acute myeloid leukemia HOVON Foundation Withdrawn No outcome recorded
Phase 2 NCT04582864 May 2021 → Mar 2024 acute myeloid leukemia Washington University School of Medicine Terminated No outcome recorded
Phase 2 NCT03739606 Oct 2020 CD4+/CD56+ hematodermic neoplasm, Hodgkins lymphoma, Philadelphia-positive myelogenous leukemia, acute biphenotypic leukemia +3 City of Hope Medical Center Withdrawn No outcome recorded
Phase not stated1 trial
— NCT04678466 — acute myeloid leukemia MacroGenics No longer available No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2020-12-06 MacroGenics Results MacroGenics Presents Flotetuzumab Data in Patients with Refractory Acute Myeloid Leukemia at the 2020 ASH Annual Meeting macrogenics.com ↗
In the open label study of flotetuzumab, 44 AML patients had disease classified as either PIF or ER6.
2020-10-15 MacroGenics Results MacroGenics Announces Flotetuzumab Publication in Blood Advances macrogenics.com ↗
The same gene signature was shown to be associated with an increased probability of this subset of patients to respond to flotetuzumab.
2020-09-22 MacroGenics Results MacroGenics Announces Publication of Flotetuzumab Interim Phase 1/2 Clinical Trial Results in Blood macrogenics.com ↗
The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS), the majority reported as grade 1-2.
2020-06-03 MacroGenics Results MacroGenics Announces Publication in Science Translational Medicine Supporting Flotetuzumab Pivotal Study in Patients with Refractory Acute Myeloid Leukemia macrogenics.com ↗
The data indicated that an inflammatory signature related to INF-γ gene expression was predictive of resistance to chemotherapy and potential response to flotetuzumab immunotherapy in patients with primary refractory or early relapsed AML.
2020-04-27 MacroGenics Results MacroGenics Announces Presentation of Flotetuzumab Translational Data at the 2020 AACR Annual Meeting macrogenics.com ↗
The data suggests that TP53 mutations in AML associate with an immune-infiltrated tumor microenvironment (TME) characterized by high expression of IFN-γ signaling molecules and immune checkpoints.
2019-12-09 MacroGenics Results MacroGenics Presents Flotetuzumab Data in Patients with Primary Induction Failure and Early Relapsed Acute Myeloid Leukemia at the 2019 ASH Annual Meeting macrogenics.com ↗
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced updated results from a Phase 1/2 dose expansion study of flotetuzumab, an investigational, bispecific CD123 x CD3 DART® molecule in patients with primary induction failure and early relapsed acute myeloid leukemia (AML).
2018-12-03 MacroGenics Results Phase 1 Expansion Cohort Oral Presentations for Flotetuzumab, MacroGenics’ CD123 x CD3 DART® Molecule, in Relapsed/Refractory Acute Myeloid Leukemia Presented at 60th ASH Annual Meeting macrogenics.com ↗
Flotetuzumab demonstrated 29.4% complete response rate in evaluable primary refractory AML patients

All press releases naming this drug 15 releases

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Flotetuzumab “This phase II trial studies how well flotetuzumab works in treating patients with CD123 positive blood cancer that has come back or does not respond to treatment.” NCT03739606 ↗
7

NCT05506956 ↗

NCT04678466 ↗

NCT04681105 ↗

NCT05063123 ↗

NCT04582864 ↗

NCT02152956 ↗

NCT04158739 ↗

Known as MGD-006 ChEMBL registry synonym — accepted as the source's own label CHEMBL3990038 ↗
Known as NSC#808294 “A Phase 1 Trial of the CD123 X CD3 DART Molecule Flotetuzumab (NSC#808294) in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia” NCT04158739 ↗
Known as RES-234 ChEMBL registry synonym — accepted as the source's own label CHEMBL3990038 ↗
Known as S-80880 ChEMBL registry synonym — accepted as the source's own label CHEMBL3990038 ↗
Modality Monoclonal antibody “Immunotherapy with monoclonal antibodies, such as flotetuzumab, may help the body's immune system attack the cancer” NCT03739606 ↗
Route Intravenous “Given IV” NCT03739606 ↗
Target IL3RA “Interleukin-3 receptor subunit alpha binding agent” CHEMBL3990038 ↗