UCART19

Unassigned

New Medicines

Acute lymphoblastic leukaemia (ALL) including relapsed/refractory B-cell in adults and children

Information

Advanced therapy medicinal product (ATMP)
Servier
Pfizer

Development and Regulatory status

Phase I Clinical Trials
Phase I Clinical Trials
Phase I Clinical Trials
Apr 19 · PI for haematological malignancies [4].
Mar 18 · Servier submits a pediatric investigation plan to the European Medicines Agency (EMA) [3].
Nov 15 · Pfizer and Servier enter into an exclusive global license and collaboration agreement to co-develop and commercialize UCART19. Under the terms of the agreement, Pfizer and Servier will work together on a joint clinical development program for UCART19 and share development costs. Pfizer will be responsible for potential commercialization of UCART19 in the US, and Servier will retain marketing rights in countries outside the US [3].

Category

An engineered allogeneic chimeric antigen receptor (CAR) T-cell product, manufactured from healthy donor cells, in which TRAC and CD52 genes have been disrupted to allow administration in non-HLA matched patients
ALL is the most common cancer in children. Global incidence is about 3 per 100,000 population, with about 3 out of 4 cases occurring in children aged under 6 years [1].
Acute lymphoblastic leukaemia (ALL) including relapsed/refractory B-cell in adults and children
Intravenous infusion

Trial or other data

Apr 20 · PI long-term follow-up study (NCT02735083) is enrolling by invitation. Patients will be followed for up to 15 years [5].
Apr 20 · PI studies, PALL and CALM, are recruiting at hospitals in the UK, including Kings College, UCL Great Ormond Street and The Christie [5].
Dec 18 · Allogene Therapeutics and Servier release pooled analysis results of two PI trials, including the PALL study (NCT02808442) and the CALM study (NCT02746952). The CALM study was initiated in Aug 16 to evaluate the safety and tolerability of ascending doses of UCART19 (dose-escalation part) given as a single infusion in patients with relapsed / refractory (R/R) B-cell acute lymphoblastic leukaemia (B-ALL), to determine the maximum tolerated dose (MTD), the recommended dose and the lymphodepletion regimen. 40 patients will be recruited in the UK, US and France [2,3].
Mar 18 · Results reported from PI study (NCT02808442) show that UCART19 induced molecular remission ahead of allogeneic haematopoietic stem cell transplantation in high risk paediatric patients with CD19+ relapsed/refractory B-cell acute lymphoblastic leukaemia [3].
Jun 16 · PI study (NCT02808442) to assess the safety and efficacy of UCART19 IV infusion to induce molecular remission in paediatric patients (aged 6 months to < 16 years) with relapsed or refractory B acute lymphoblastic leukaemia starts. The trial intends to enrol approximately 18 patients in the US, UK, Belgium and France. Collection of primary outcome data is due to complete Apr 20 [2].