CARPALL
Research type
Research Study
Full title
Immunotherapy with CD19 CAR redirected T-cells for high risk relapsed paediatric CD19+ acute lymphoblastic leukaemia and other haematological malignancies
IRAS ID
179225
Contact name
Fernanda Castro
Contact email
Sponsor organisation
University College London
Eudract number
2015-001144-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Acute lymphoblastic leukaemia (ALL) is the commonest childhood cancer. While most children and young adults with ALL are curable with chemotherapy, 20% of patients will relapse and even with a stem cell transplant (SCT) only 40-50% of relapsing patients survive long term. Patients who relapse after SCT have up to now been incurable. Similarly, Burkitt’s lymphoma in children, while curable with chemotherapy in most (90%) children, also has poor outcomes for patients who relapse, with salvage rates of only 20-30%. Since these patients have frequently had the maximal tolerable dose of chemo/radiotherapy, novel therapies are urgently required for such patients.
In this study we will investigate whether immune cells (T-cells) from the patient that have been redirected to recognise the CD19 molecule on leukaemia/lymphoma cells can safely treat/prevent relapse in children and young adults with high risk ALL and other B-cell malignancies. We will take some of the patient’s own T-cells from the blood and genetically modify them in the laboratory with a virus so they express a CD19 Chimeric Antigen Receptor (CD19CAR) which enables them to “see” leukaemia/lymphoma cells and kill them. These modified cells will then be given as a single intravenous dose to the patient after low dose chemotherapy. Patients will be observed as inpatients for 2 weeks after the CD19CAR T-cells in case of any toxicity and will then be followed up as outpatients with regular blood and bone marrow tests for 2 years to determine if this approach is safe and effective at preventing relapse. We will address whether responses are durable and if this treatment can be used as an alternative to SCT. We plan to treat 15 patients in total in 3 centres in the UK. This approach may help to treat/prevent relapse in patients with high risk ALL/ and other B-cell malignancies.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0283
Date of REC Opinion
29 Mar 2016
REC opinion
Further Information Favourable Opinion