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

Sponsor
Institut de Recherches Internationales Servier (Other)
Overall Status
Completed
CT.gov ID
NCT02746952
Collaborator
ADIR, a Servier Group company (Industry)
25
Enrollment
9
Locations
1
Arm
47.9
Actual Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: UCART19
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Jul 28, 2020
Actual Study Completion Date :
Jul 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: UCART19

Biological: UCART19
Other Names:
  • S68587

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose escalation part: Dose Limiting Toxicities (DLTs) occurence. Dose expansion part: AE throughout the study. [Dose Escalation: Up to day 28 post first UCART19 infusion. Dose Expansion: From inclusion to Month 12]

    Secondary Outcome Measures

    1. Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability [From inclusion to Month 12]

      Adverse events assessed according to NCI-CTCAE v5.0 criteria

    2. Objective Remission Rate [At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12]

      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)

    3. 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]

    4. Time to remission [From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12]

    5. 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]

    6. Overall Survival (OS) [From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy 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

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114
    2 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    3 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    4 Hôpital Saint-Antoine PARIS Cedex 12 France 75571
    5 Hôpital Saint-Louis Paris France 75010
    6 Kyushyu University Hospital Fukuoka Japan 812-8582
    7 Hokkaido University Hospital Sapporo Japan 060-8648
    8 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS
    9 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Institut de Recherches Internationales Servier
    • ADIR, a Servier Group company

    Investigators

    • Principal Investigator: Reuben Benjamin, MD, PhD, King's College Hospital NHS Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Institut de Recherches Internationales Servier
    ClinicalTrials.gov Identifier:
    NCT02746952
    Other Study ID Numbers:
    • CL1-68587-002
    • 2016-000296-24
    First Posted:
    Apr 21, 2016
    Last Update Posted:
    Oct 1, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Oct 1, 2021