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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
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The aims of this study are to make sure these KCAT19 T cells can be made in the lab, assess if these therapies are safe and also obtain some initial information that these CAR T cells work in patients with B-cell malignancies.
Following patent's informed consent and registration into the trial, allogeneic HLA-matched cord blood donor T cells will be couriered to the Centre for Cell, Gene & Tissue Therapeutics (CCGTT) at the Royal Free Hospital (RFH) where the KCAT19 T cells will be manufactured. The first 3 patients treated on KCAT19 will be HLA matched 4-6/6 with a cord-blood donor and the remaining patients registered will be HLA matched 0-6/6 if confirmed by the IDMC.
KCAT19 T cells are classified as advanced therapy investigational medicinal products (ATIMPs) and manufacture will take approximately 15 days.
Briefly, the allogeneic cord-blood derived T cells are grown in the presence of a lentivirus which transfers specific genes into the T cells (part of the white blood cells). The genes enable the T cells to express a protein which can recognise a target protein (CD19) present on the surface of the malignant B-cells and attack them. The genetically modified cells are tested to ensure they comply with the specified quality release criteria and frozen at RFH. The ATIMPs are couriered to the trial site with a special shipper (maintaining temperature below -130C) to be administered to the patient when needed. During the ATIMP manufacturing period, patients may receive "holding" chemotherapy or immunotherapy as per institutional practice to maintain disease control. Prior to infusion of the KCAT19 T cells, patients will be admitted to hospital to have pre-conditioning therapy with 2 anticancer drugs: cyclophosphamide and fludarabine.
Patients will then receive the KCAT19 T cell infusion on day 0. The KCAT19 T cells are given as an intravenous infusion. Patients will be closely monitored at the participating trial site for a minimum of 14 days after the KCAT19 T cells infusion with regular observations and blood tests (detailed in the protocol) to assess for potential toxicities. Disease assessment will take place at; baseline, month 1,month 6 and month 12 post-KCAT19 T cell infusion.
Following discharge, patients will be followed up monthly for the first 6 months, then 6 weekly until 12 months post KCAT19 T infusion,followed by quarterly visits for a further year before annual visits until the end of the trial is declared (Year 3 - Year 15).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Cellular;Gene Therapy;Immunotherapy;
You can take part if:
You may not be able to take part if:
1. CD19 negative disease 2. Active CNS involvement of disease 3. Diagnosis of chronic lymphocytic leukaemia/ small lymphocytic lymphoma or Burkitt lymphoma 4. Active hepatitis B,C or HIV infection 5. Oxygen saturation ≤ 90% on air 6. Bilirubin >2 x upper limit of normal 7. GFR <30ml/min/1.73m2 8. Women who are pregnant or breast feeding 9. Stem Cell Transplant patients only: active significant acute GvHD (overall Grade ≥ II,Modified Glucksberg criteria) or moderate/severe chronic GvHD (NIH consensus criteria) requiring immunosuppressive therapy and/or systemic steroids (see appendix 5) 10. Karnofsky score <60% (see appendix 2) 11. Known allergy to albumin or DMSO 12. Patients receiving corticosteroids at a dose of >5 mg prednisolone per day (or equivalent) that cannot be discontinued 13. Life expectancy <3 months 14. Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction <40% 15. Patients who can reasonably access autologous CD19 CAR treatment as part of standard of care or a clinical trial*
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University College London and funded by Medical Research Council (MRC) .
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Read full details
for Trial ID: CPMS 54307
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