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Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant
Sponsor: University College, London
Summary
This is an open label, non-randomised, multicentre Phase I to determine the safety of tacrolimus-resistant autologous EBV-specific cytotoxic T-cells (EBV CTL) and compare their expansion/persistence with control EBV CTL in solid organ transplant patients with post-transplant lymphoproliferative disease (PTLD). Each patient will receive an infusion of two ATIMPs - autologous EBV CTL retrovirally transduced with (a) a calcineurin mutant (CNA12) that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8).
Key Details
Gender
All
Age Range
1 Year - 70 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2019-05-31
Completion Date
2025-05-15
Last Updated
2024-05-17
Healthy Volunteers
No
Interventions
Autologous EBV-CTL transduced with vector SFG-CNA12
Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the retroviral vector SFG-CNA12 conferring resistance to tacrolimus
Autologous EBV-CTL transduced with control vector SFG-CNA8
Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the control retroviral vector SFG-CNA8
Leucapheresis
Patients will undergo an unstimulated leucapheresis to isolate the required immune cells to produce the EBV-CTLs
Locations (2)
Great Ormond Street Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom