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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
29/09/2017
Funder:
NIHR/HTA
Sponsor:
UCL
Chief Investigator:
Professor Karl Peggs
Recruitment target:
20
EudraCT number:
2016-004027-22
Contact details:
ctc.allcar19@ucl.ac.uk
Lay summary:
ALLCAR19
Immunotherapy for high risk/relapsed CD19+ Acute Lymphoblastic Leukaemia using CAR T-cells to target CD19
Description
Design:
ALLCAR19 is a multi-site, non-randomised phase I trial in adults with high risk or refractory CD19+ B-cell Acute Lymphoblastic Leukaemia.  The Advanced Therapy Investigational Medicinal Product (ATIMP) tested in this study is CD19CAT-41BBζ CAR T-cells (referred to as CD19CAR T-cells). These are Chimeric Antigen Receptor (CAR) T-cells genetically modified to recognise the CD19 protein present on the leukaemia cells and attack them.
A total of twenty patients will be treated at 3 participating sites.

Treatment:
Patients undergo leucapheresis for generation of the ATIMP and the CD19CAR T-cells are manufactured in a laboratory at GOSH. The ATIMP takes approximately 15days to generate.

Patients receive lymphodepleting chemotherapy of Cyclophosphamide 60mg/kg/day IV for 1 day (day -6) and Fludarabine 30mg/m2/day IV for 3 days (Day-5 to day-3). If patients meet the eligibility criteria for the infusion they will receive 2 intravenous injections of the ATIMP (CD19CAR T-cells) as a split dose on Day 0 and Day 9 to reduce the risk of developing unacceptable side effects. 

We aim to treat 20 patients at 3 participating sites.

Key inclusion/exclusion criteria: Age 16-65 years, high risk or relapsed histologically confirmed CD19+ B-ALL. Patients should not have overt CNS involvement or isolated extramedullary disease, or active hepatitis B, C or HIV infection. Bilirubin, oxygen saturation and GFR must be of acceptable levels. Patients with arrhythmias, significant cardiac disease, active or chronic GVHD requiring immunosuppressants are excluded from the study.
Duration of recruitment: 2 years
Aim
The primary aim of the trial is assessing toxicity following CD19CAR T-cell administration (grade 3-5 toxicity causally related to the ATIMP) and feasibility of adequate leucapheresis collection and generation of CD19CAR T-cells evaluated by number of therapeutic products generated. Secondary endpoints include response including depth of response at 1 and 3 months post infusion, persistence and frequency of circulating CD19CAR transduced T-cells in peripheral blood, incidence and duration of hypogammaglobulinaemia and B-cell aplasia, relapse rate, Disease-Free Survival and Overall Survival at 1 and 2 years after treatment.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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