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

Completed · Phase 1

Conditions studied: B-cell Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT02746952

Run by

Institut de Recherches Internationales Servier

People needed

25

Starts

2016-08-01

Expected to finish

2020-07-28

Last updated by the study team

2021-10-01

Who can join

Age: 16 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participant
• Age ≥ 16 years
• Patient with relapsed or refractory CD19 positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options
• Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
• Eastern Cooperative Oncology Group (ECOG) performance status < 2

You may not qualify if…

• Previous treatment with gene or gene-modified cell therapy medicine products or adoptive T cell therapy
• Use of previous anti-leukemic therapy (including approved therapies and other investigational products) within 5 half-lives prior to UCART19 administration
• CD19 negative B-cell leukaemia
• Burkitt cell or mixed lineage acute leukaemia

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Hôpital Saint-Louis — Paris, France
• Hôpital Saint-Antoine — Paris, France
• Kyushyu University Hospital — Fukuoka, Japan
• Hokkaido University Hospital — Sapporo, Japan
• King's College Hospital NHS Foundation Trust — London, United Kingdom
• The Christie NHS Foundation Trust — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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