Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
GOSH Charity and Children with Cancer UK; JP Moulton Charitable Foundation
Chief Investigator:
Professor Persis Amrolia
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Immunotherapy with CD19/22 CAR redirected T-cells for high risk/relapsed paediatric CD19+ and / or CD22+ acute lymphoblastic leukaemia and other haematological malignancies
A multi-centre, non-randomised, open label phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and young adults with high risk, relapsed CD19+ and/or CD22+ haematological malignancies (chiefly ALL and Burkitt’s lymphoma). The ATIMP tested in cohort 1 and 2 of this study is CD19CAT-41BBζ CAR T-cells (referred to as CD19CAR T-cells). The ATIMP tested in cohort 3 of this study is CD19CAT-CD22 9A8-41BBZ CAR T-cells (referred to as CD19/22CAR 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.

A total of 33 patients will be treated at 3 participating sites.

Patients will undergo an unstimulated leucapheresis which will be sent to GCT-GOSH for manufacture of CD19/22CAR T-cells.  ATIMP manufacture takes about 15 days. During this period, patients may receive “holding” chemotherapy to maintain disease control.
Prior to CD19/22CAR T-cell infusion patients will receive lymphodepleting chemotherapy: fludarabine 30 mg/m2 iv day -7 to -3 and cyclophosphamide 0.5 g/m2 iv  day -4 to -2 . A single dose of 106/kg cryopreserved CD19/22CAR+ T-cells will be administered intravenously. Patients will be followed up regularly (with daily, weekly and monthly visits) until 2 years post-CD19/22CAR T-cell infusion.  After 2 years patients will continue to be followed up annually until 10 years post ATIMP infusion.

Key inclusion/exclusion criteria: age 24 years or younger; diagnosis of high risk/relapsed CD19+ and/or CD22+ haematological malignancy. Patients with active HepB, HepC or HIV infection; with acute or chronic GVHD requiring steroids are excluded from the study. Creatinine and bilirubin need to be no more than 3xULN.
Duration of recruitment: Anticipated recruitment for the feasibility will be over 5.5 years. 
The aim of the study is to evaluate the safety, efficacy and duration of response of the CAR T-cells in children and young adults with high risk / relapsed CD19+ and/or CD22+ malignancies.
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
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