Clinical Trial - NCT02746952

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

Active, not recruiting

Sponsor: Institut de Recherches Internationales Servier

Collaborators: ADIR, a Servier Group company

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02746952

Protocol Info

Short Description: Phase I of UCART19 in Rel./Ref. CD-19 Positive B-ALL
Long Description: Phase I, open label, dose-escalation study 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) CALM study (UCART19 in Advanced Lymphoid Malignancies)
MGH Status: Open
Sponsor: Institut de Recherches Internationales Servier
Disease Program: Cellular

Next Steps


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Purpose

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.
Condition Title Intervention Phase
B-cell Acute Lymphoblastic Leukemia UCART19 Phase 1
Study Type Interventional
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)

Primary Outcome Measures

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] [Designated as safety issue: ]


Secondary Outcome Measures

Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability [Time Frame: From inclusion to Month 12] [Designated as safety issue: ]

Objective Remission Rate [Time Frame: At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12] [Designated as safety issue: ]

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] [Designated as safety issue: ]

Time to remission [Time Frame: From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12] [Designated as safety issue: ]

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] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12] [Designated as safety issue: ]

Estimated Enrollment: 23
Study Start Date: August 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: May 2020
Arms Assigned Interventions

Experimental:UCART19

Biological:UCART19

Eligibility

Ages Eligible for Study: 69 Years-69 Years

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02746952

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Pennsylvania
    • Hospital of the University of Pennsylvania Philadelphia, Pennsylvania, United States, 19104
  • United States, Texas
    • University of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030
  • France,
    • Hôpital Saint-Antoine PARIS Cedex 12, , France, 75571
    • Hôpital Saint-Louis Paris, , France, 75010
  • Japan,
    • Kyushyu University Hospital Fukuoka, , Japan, 812-8582
    • Hokkaido University Hospital Sapporo, , Japan, 060-8648
  • United Kingdom,
    • King's College Hospital NHS Foundation Trust London, , United Kingdom, SE5 9RS
    • The Christie NHS Foundation Trust Manchester, , United Kingdom, M20 4BX

Sponsors and Collaborators

Institut de Recherches Internationales Servier

ADIR, a Servier Group company

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02746952
Other Study ID Numbers: 2016-000296-24
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020