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)

Institut de Recherches Internationales Servier9 sites in 4 countries25 target enrollmentAugust 1, 2016

ConditionsB-cell Acute Lymphoblastic Leukemia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-cell Acute Lymphoblastic Leukemia
Sponsor: Institut de Recherches Internationales Servier
Enrollment: 25
Locations: 9
Primary Endpoint: Dose escalation part: Dose Limiting Toxicities (DLTs) occurence. Dose expansion part: AE throughout the study.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2016

End Date

July 28, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institut de Recherches Internationales Servier

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Dose escalation part: Dose Limiting Toxicities (DLTs) occurence. Dose expansion part: AE throughout the study.

Time Frame: Dose Escalation: Up to day 28 post first UCART19 infusion. Dose Expansion: From inclusion to Month 12

Secondary Outcomes

Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability(From inclusion to Month 12)
Duration of remission(From the time that response criteria are first met until the date of progression or death (whatever the reason of death), whichever occurs first, assessed up to Month 12)
Overall Survival (OS)(From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12)
Objective Remission Rate(At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12)
Progression Free Survival (PFS)(From the date of UCART19 administration until the date of progression or the date of death (whatever the reason of death), whichever occur first, assessed up to Month 12)
Time to remission(From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12)