Phase I, Open Label, Dose-escalation Study to Evaluate the Safety, Expansion and Persistence of a Single Dose of UCART19 (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor), Administered Intravenously in Patients With Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukaemia (B-ALL)
Phase of Trial: Phase I
Latest Information Update: 22 Oct 2017
At a glance
- Drugs UCART 19 (Primary)
- Indications Acute lymphoblastic leukaemia
- Focus Adverse reactions; First in man
- Acronyms CALM
- Sponsors Servier
- 20 Apr 2017 Planned number of patients changed from 18 to 40.
- 09 Mar 2017 According to a Sevier media release, the US FDA has cleared an Investigational new Drug (IND) application for UCART-19 facilitating expansion of this trial to include several centers in the US, including the MD Anderson Cancer center in Houston (Texas).
- 01 Feb 2017 According to a Servier media release, the company submitted an Investigational New Drug (IND) application for UCART-19 to the US FDA on February 1, 2017.