Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia (CALM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02746952 |
Recruitment Status :
Completed
First Posted : April 21, 2016
Last Update Posted : October 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
B-cell Acute Lymphoblastic Leukemia | Biological: UCART19 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | August 1, 2016 |
Actual Primary Completion Date : | July 28, 2020 |
Actual Study Completion Date : | July 28, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: UCART19 |
Biological: UCART19
Other Name: S68587 |
- 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 ]
- 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
- 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)
- 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 ]
- Time to remission [ Time Frame: 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 ]
- Overall Survival (OS) [ Time Frame: From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12 ]

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Ages Eligible for Study: | 16 Years to 69 Years (Child, Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746952
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 |
Principal Investigator: | Reuben Benjamin, MD, PhD | King's College Hospital NHS Trust |
Study Data/Documents: Individual Participant Data Set

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Institut de Recherches Internationales Servier |
ClinicalTrials.gov Identifier: | NCT02746952 |
Other Study ID Numbers: |
CL1-68587-002 2016-000296-24 ( EudraCT Number ) |
First Posted: | April 21, 2016 Key Record Dates |
Last Update Posted: | October 1, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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:
In addition, access can be requested for all interventional clinical studies in patients:
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Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | After Marketing Authorisation in EEA or US if the study is used for the approval. |
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. |
URL: | https://clinicaltrials.servier.com/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |