Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia

The study is in two parts: a dose escalation then a safety dose expansion. The purpose of the dose escalation part is 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. The purpose of the safety dose expansion is to assess the safety and tolerability of the RD for UCART19.

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02746952.

Trial PhasePhase I

Trial Typetreatment

Lead OrganizationInstitut de Recherches Internationales Servier

• Primary IDCL1-68587-002
• Secondary IDsNCI-2017-01223, 2016-000296-24
• ClinicalTrials.gov IDNCT02746952