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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
15/06/2016
Funder:
Bloodwise
Sponsor:
UCL
Chief Investigator:
Professor Karl Peggs
Recruitment target:
12
EudraCT number:
2015-000348-40
Contact details:
ctc.cobalt@ucl.ac.uk
Lay summary:
COBALT
Evaluation of CAR19 T-cells as an optimal bridge to allogeneic transplantation.
Description
Design:
Single centre, single arm dose-escalation phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults with resistant or relapsed DLBCL. The ATIMP tested in this study is autologous RQR8/4G7 CAR T-cells (referred to as CAR19 T cells). These are Chimeric Antigen Receptor (CAR) T-cells genetically modified to recognise the CD19 protein present on the lymphoma cells and attack them.
Up to twelve patients will be treated on this study.

Treatment:
Patients will undergo leucapheresis for generation of the ATIMP. ATIMP manufacture will be at GOSH and will take 3 weeks in which time patients should proceed with a further cycle of standard salvage, and should not receive rituximab.  Patients will receive pre-conditioning with fludarabine and cyclophosphamide prior to infusion of a single dose of CAR19 T-cells. An escalating dose protocol will be employed to identify a minimum effective dose of CAR19 T-cells. 

Three dose cohorts are planned:
  • Dose Level 1: 2x105 CAR19 T-cells/kg
  • Dose Level 2: 1x106 CAR19 T-cells/kg
  • Dose Level 3: 5x106 CAR19 T-cells/kg
Key inclusion/exclusion criteria: age 16-65 years, diagnosis of CD19+ DLBCL, primary resistant or relapsed disease , or relapse post ASCT , potential candidate for allogeneic SCT. Patients with history of heart disease, hypertension, CNS involvement, active HBV, HCV, HIV are excluded from the study. Liver and kidney function tests need to be within acceptable limits.  Patients should have had rituximab within 2 months of infusion. 
Duration of recruitment: Anticipated recruitment for the feasibility will be over 2 years. 
Aim
Although the classic phase I escalation design focuses primarily on toxicity endpoints, the overall aim to demonstrate potential viability as a bridge to transplantation requires evaluation of efficacy in terms of disease response as a key secondary endpoint, as eligibility for allogeneic transplantation is determined by response/disease status prior to transplantation.
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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London
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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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