AMG 553 / Amgen - LARVOL DELTA

Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Amgen | N=40 ➔ 0 | Not yet recruiting ➔ Withdrawn

CAR T-Cell Therapy • Enrollment change • Trial withdrawal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Amgen; Trial completion date: Aug 2029 ➔ Aug 2030; Trial primary completion date: Aug 2029 ➔ Aug 2030

CAR T-Cell Therapy • Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Amgen; Trial completion date: May 2029 ➔ Aug 2029; Trial primary completion date: May 2029 ➔ Aug 2029

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Nonclinical Safety Assessment of AMG 553, an Investigational Chimeric Antigen Receptor (CAR) T-cell Therapy for the Treatment of Acute Myeloid Leukemia. (PubMed, Toxicol Sci) - "Potential AMG 553-induced cytotoxicity was assessed against a wide range of normal human primary cells and cell lines; cytotoxicity was observed against FLT3-positive AML cell lines and a percentage of primary bone marrow CD34+ cells. In conclusion, the nonclinical safety data suggest that AMG 553 can target FLT3 protein on AML cells while only affecting a percentage of normal hematopoietic stem and progenitor cells, supporting clinical development."

Clinical • IO Biomarker • Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • CD34 • FLT3

Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Amgen; Trial completion date: Dec 2026 ➔ May 2029; Initiation date: Sep 2019 ➔ Dec 2021; Trial primary completion date: Dec 2026 ➔ May 2029

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

Nonclinical safety assessment of AMG 553, an investigational anti-FLT3 CAR-T therapy. (ASCO 2019) - "AMG 553 is a novel, investigational, adoptive cellular immunotherapy for the treatment of relapsed refractory AML, consisting of autologous T cells genetically modified ex vivo to express a transmembrane chimeric antigen receptor (CAR) to target FLT3 protein on the surface of AML cells irrespective of FLT3 mutational status. The nonclinical safety data support AMG 553 as a novel therapeutic to target FLT3 protein on AML cells irrespective of FLT3 mutational status, while only affecting a percentage of normal hematopoietic stem and progenitor cells."

Clinical • IO Biomarker

Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Amgen; Initiation date: Jun 2019 ➔ Sep 2019; Trial primary completion date: Nov 2021 ➔ Dec 2026

Clinical • Trial initiation date • Trial primary completion date