NCT01195480

Immunotherapy With CD19ζ Gene-modified EBV-specific CTLs After Stem Cell Transplant in Children With High-risk Acute Lymphoblastic Leukaemia

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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Interventions

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

FacilityCityStateCountry
Klinik und Poliklinik für Kinder- und Jugendmedizin, UniversitätsklinikumEssenGermany
Hospital for Children and Adolescents III, Goethe UniversityFrankfurtGermany
Medizinische HochschuleHanoverGermany
University Children's HospitalMünsterGermany
Bristol Children's HospitalBristolUnited Kingdom
Great Ormond Street Hospital for ChildrenLondonUnited Kingdom
University College London HospitalLondonUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026