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: 13 Nov 2017
At a glance
- Drugs UCART 123 (Primary)
- Indications Acute myeloid leukaemia
- Focus Adverse reactions; First in man
- Sponsors Cellectis
- 13 Nov 2017 According to a Cellectis media release, In connection with the lifting of the clinical hold, Company agreed with the FDA to certain revisions to be implemented in protocol.
- 06 Nov 2017 According to a Cellectis media release, the US FDA has has lifted the clinical hold on Phase 1 trials of UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- 06 Nov 2017 Status changed from suspended to recruiting, according to a Cellectis media release.