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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
16/03/2017
Funder:
EU FP7
Sponsor:
UCL
Chief Investigator:
Professor Karl Peggs
Recruitment target:
12
EudraCT number:
2016-001869-85
Contact details:
ctc.card@ucl.ac.uk
Lay summary:
CARD
CAR19 Donor Lymphocytes for relapsed CD19+ malignancies following allogeneic transplantation
Description
Design: CARD is a single centre, single arm intra-patient dose-escalation phase I study in adults with relapsed CD19+ malignancies following allogeneic stem cell transplantation.  The Advanced Therapies Investigational Medicinal Product (ATIMP) tested in this study is 4G7-CARD T-cells. These are Chimeric Antigen Receptor (CAR) T-cells genetically modified to recognise the CD19 protein present on the malignant cells and attack them.  The original stem cell donor is approached to undergo leucapheresis for generation of the ATIMP. If this is not possible, the patient can undergo leucapheresis for generation of the ATIMP. The CAR T-cells are manufactured at GOSH using an automated system called Miltenyi CliniMACS Prodigy®. The ATIMP takes 3 weeks to generate, in which time patients can receive further salvage treatment appropriate to the underlying disease, avoiding rituximab.  Eligible patients are then infused with the manufactured ATIMP.
Treatment: Patients can receive up to 3 escalating doses of the CAR T-cells separated by at least 8 weeks, unless patient develops unacceptable side effects or disease responds sufficiently. Patients are then followed up regularly for 12 months after the last CAR T-cells dose and then annually until 3 years after CAR T-cells infusion. Up to 12 patients will be treated on the study
Key inclusion/exclusion criteria: aged 16-70 years, diagnosis of CD19+ malignancy having relapsed following allogeneic transplantation, Karnofsky performance status >60, absence of active GVHD requiring immunosuppression, no history of heart disease (as detailed in protocol), no CNS involvement, no treatment with rituximab within the last 3 months. 
Duration of recruitment: Anticipated duration of recruitment is 18 months. 
Aim
To evaluate the feasibility of 4G7-CARD T-cells manufacture using an automated system (ProdigyTM), and the toxicity associated with the CAR T-cells administration. 
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
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Email:
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Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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