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

Status:	Active, not recruiting
Conditions:	Blood Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	16 - 69
Updated:	11/29/2018
Start Date:	August 1, 2016
End Date:	July 2020

Phase I, Open Label, Dose-escalation Study Followed by a Safety Expansion Part 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)

The purpose of this study 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

We found this trial at

sites

Hospital of the University of Pennsylvania

3400 Spruce St
Philadelphia, Pennsylvania 19104

(215) 662-4000