Clinical Trials /

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

NCT02746952

Description:

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.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: CL1-68587-002
  • SECONDARY ID: 2016-000296-24
  • NCT ID: NCT02746952

Conditions

  • B-cell Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
UCART19S68587UCART19

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
UCART19Experimental
  • UCART19

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
      
Maximum Eligible Age:69 Years
Minimum Eligible Age:16 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicities (DLTs) occurence
Time Frame:Up to day 28 post first UCART19 infusion
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Time Frame:From inclusion to Month 12
Safety Issue:
Description:Adverse events assessed according to NCI-CTCAE v4.03 criteria
Measure:Objective Remission Rate
Time Frame:At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12
Safety Issue:
Description:Proportion of patients in whom a response among molecular complete remission (mCR), morphologic complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
Measure:Duration of remission
Time Frame: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
Safety Issue:
Description:
Measure:Time to remission
Time Frame:From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12
Safety Issue:
Description:
Measure:Progression Free Survival (PFS)
Time Frame: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
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Institut de Recherches Internationales Servier

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