Phase I, Open Label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of a Single Dose of UCART123 (Allogeneic Engineered T Cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Relapsed/Refractory Acute Myeloid Leukemia, and Patients With Newly Diagnosed High-risk Acute Myeloid Leukemia
Phase of Trial: Phase I
Latest Information Update: 18 Sep 2017
At a glance
- Drugs UCART 123 (Primary)
- Indications Acute myeloid leukaemia
- Focus Adverse reactions; First in man
- Sponsors Cellectis
- 04 Sep 2017 According to a Cellectis media release, the US FDA has placed a clinical hold on both UCART123 ongoing Phase 1 studies, respectively in acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- 04 Sep 2017 Status changed from recruiting to suspended according to a Cellectis media release.
- 27 Jun 2017 According to a Cellectis media release, Dr. Monica Guzman, an associate professor of pharmacology in medicine at Weill Cornell Medicine, is a co-principal investigator of the study.