Study Summary
The aim of this clinical 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 Haematopoietic Stem Cell Transplantation (HSCT).
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donor-derived EBV-specific cytotoxic T-cells (EBV-CTL) transduced with the retroviral vector SFGalpha-CD19-CD3zetaGENETIC
All patients will be treated at the same total dose level of 2 x 10\^8/m2
Irradiated donor-derived Lymphoblastoid Cell LineBIOLOGICAL
The initial cohort of 5 patients (regardless of arm of study) will be treated as described. If transduced CTL infusion is safe in this initial cohort and real-time DNA PCR studies demonstrate that transduced CTL are undetectable in \> 50% of patients by 2 months post-infusion, the remaining 25 patients (in either arm of the study) will be treated as above but with an additional vaccination of CD19-zeta-transduced EBV-LCL infusion.
Vaccination will consist of 3 doses of 5 x 10\^6 irradiated (70Gy) donor-derived EBV-lymphoblastoid cell line used to generate CTL and will be administered subcutaneously into the thigh (volume 0.3 ml) at day -2, week 4 and 8 post-transduced CTL infusion.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Klinik und Poliklinik für Kinder- und Jugendmedizin, Universitätsklinikum | Essen | Germany | |
| Hospital for Children and Adolescents III, Goethe University | Frankfurt | Germany | |
| Medizinische Hochschule | Hanover | Germany | |
| University Children's Hospital | Münster | Germany | |
| Bristol Children's Hospital | Bristol | United Kingdom | |
| Great Ormond Street Hospital for Children | London | United Kingdom | |
| University College London Hospital | London | United Kingdom |