Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia
NCT ID: NCT02746952
Last Updated: 2021-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2016-08-01
2020-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UCART19
UCART19
Interventions
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UCART19
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
69 Years
ALL
No
Sponsors
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ADIR, a Servier Group company
INDUSTRY
Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Principal Investigators
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Reuben Benjamin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Hôpital Saint-Louis
Paris, , France
Hôpital Saint-Antoine
Paris, , France
Kyushyu University Hospital
Fukuoka, , Japan
Hokkaido University Hospital
Sapporo, , Japan
King's College Hospital NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Benjamin R, Graham C, Yallop D, Jozwik A, Mirci-Danicar OC, Lucchini G, Pinner D, Jain N, Kantarjian H, Boissel N, Maus MV, Frigault MJ, Baruchel A, Mohty M, Gianella-Borradori A, Binlich F, Balandraud S, Vitry F, Thomas E, Philippe A, Fouliard S, Dupouy S, Marchiq I, Almena-Carrasco M, Ferry N, Arnould S, Konto C, Veys P, Qasim W; UCART19 Group. Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies. Lancet. 2020 Dec 12;396(10266):1885-1894. doi: 10.1016/S0140-6736(20)32334-5.
Benjamin R, Jain N, Maus MV, Boissel N, Graham C, Jozwik A, Yallop D, Konopleva M, Frigault MJ, Teshima T, Kato K, Boucaud F, Balandraud S, Gianella-Borradori A, Binlich F, Marchiq I, Dupouy S, Almena-Carrasco M, Pannaux M, Fouliard S, Brissot E, Mohty M; CALM Study Group. UCART19, a first-in-class allogeneic anti-CD19 chimeric antigen receptor T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (CALM): a phase 1, dose-escalation trial. Lancet Haematol. 2022 Nov;9(11):e833-e843. doi: 10.1016/S2352-3026(22)00245-9. Epub 2022 Oct 10.
Study Documents
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Document Type: Individual Participant Data Set
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Informed Consent Form
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Study-level clinical trial data
View DocumentOther Identifiers
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2016-000296-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CL1-68587-002
Identifier Type: -
Identifier Source: org_study_id
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