Trial Details
Trial status:
Recruitment start date:
Chief Investigator:
Professor Persis Amrolia
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Immunotherapy with CD19? gene modified EBV-specific CTLs after stem cell transplant in children with high-risk acute lymphoblastic leukaemia
Design: a multi-site, non-randomised, phase I/II, paediatric trial with 2 arms. The  Advanced Therapy Medicinal product (ATMP) tested in the study is donor-derived EBV-specific cytotoxic T-cells (EBV-CTL) transduced with retroviral vector carrying CD19 chimaeric antigen receptor. 15 patients will be treated prophylactically with the EBV-CTL and a further cohort of 15 patients will be treated pre-emptively based on minimal residual disease post HSCT. If the EBV-CTL cannot be detected after 5 patients have been treated, subsequent patients will receive vaccination with irradiated donor-derived LCL (2nd ATMP) to test whether EBV-CTL persistence will be improved.
Treatment: Patients will receive lymphodepletion with Fludarabine. Patients will receive the EBV-CTL infusion as 2 intravenous injections over consecutive days. If the CD19-CTL infusion is safe but the ATIMP is not detectable in > 50% of the 1st five patients, subsequent patients in either arm of the trial will be treated as above but with additional LCL vaccination (2nd ATIMP) postCD19-CTL infusion.
Key inclusion/exclusion criteria: Pre-emptive arm –patients in first remission or with relapsed CD19+ B cell precursor ALL who are undergoing allogeneic stem cell transplant (ASCT). Prophylaxis arm - any patient with ALL relapsing in bone marrow after allogeneic HSCT achieving remission after re-induction, who is a candidate for second HSCT. Stem cell donors must be EBV sero-positive and HLA-matched or a single antigenic/allelic (7/8) mismatch with recipient. Patients must not have active acute or significant chronic GVHD requiring steroids, pre-existing lung disease or active intercurrent infection. Patients cannot be serologically positive for Hepatitis B, C or HIV pre-HSCT.
Duration of recruitment: 2-3 years
The primary aim of the trial is to evaluate the feasibility, safety and biological effect of adoptive transfer of CD19ζ chimaeric receptor transduced donor-derived EBV-specific cytotoxic T-lymphocytes (EBV-CTL) in patients with high-risk or relapsed B cell precursor ALL after allogeneic HSCT. Primary endpoints are toxicity within 12 weeks of infusion attributable to transfer of CD19- ζ transduced CTL and biological efficacy, assessed by effect of CD19- ζ transduced CTL on Minimal Residual Disease levels in the bone marrow in the first year post infusion.
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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