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

September 24, 2021 updated by: Institut de Recherches Internationales Servier

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UCART19
Biological: UCART19
Other Names:
  • S68587

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Time Frame: From inclusion to Month 12
Adverse events assessed according to NCI-CTCAE v5.0 criteria
From inclusion to Month 12
Objective Remission Rate
Time Frame: 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)
At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12
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
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
Time to remission
Time Frame: From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12
From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12
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
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
Overall Survival (OS)
Time Frame: From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12
From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Internationales Servier

Collaborators

ADIR, a Servier Group company

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

July 28, 2020

Study Completion (Actual)

July 28, 2020

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1-68587-002
  • 2016-000296-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing Access Criteria

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Study Data/Documents

  1. Individual Participant Data Set
  2. Study Protocol
  3. Statistical Analysis Plan
  4. Informed Consent Form
  5. Clinical Study Report
  6. Study-level clinical trial data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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